This chapter contains sections titled: The Moral Critique of Research on Animals The Uses of Animals in Research The Response of the Research Community to the Moral Critique of Animal Research Practical Resolution References Further reading.

In lieu of an abstract, here is a brief excerpt of the content:Women and Health Research:A Report from the Institute of MedicineAnna C. Mastroianni (bio), Ruth Faden (bio), and Daniel Federman (bio)In recent years, claims have been made by segments of the research community and by women's health advocacy groups that clinical research practices and policies have not benefitted women's health to the same extent as men's health. Central to these claims has been (...) an assertion that women have been inadequately represented as subjects of clinical studies and that as a result neither health conditions unique to women—e.g., menopause—nor women's manifestations of health problems affecting both sexes—e.g., heart disease—have been investigated sufficiently.The scientific community, including federal agencies that sponsor and regulate clinical studies, is increasingly responsive to these claims and is taking steps to raise the level of women's participation in clinical studies. Controversy and concern have surrounded these actions, however. Two of the claims that have been made are: (1) that women are more difficult to study than men because of their cyclical hormonal changes; and (2) that conducting gender-specific subgroup analyses would increase the size of study populations, raise the cost of studies, and thereby reduce the number of studies that could be performed with the limited resources available. In addition, controversy over the inclusion of women of childbearing potential and pregnant women has been particularly salient. Concerns have been expressed about avoiding potential harm to existing or potential fetuses and about the possible legal and financial ramifications of such harm. A further concern involves the perceived difficulties in enrolling women in studies and retaining them for the duration of the studies.Against this backdrop, the Office of Research on Women's Health at the National Institutes of Health (NIH) asked the Institute of Medicine (IOM) in October 1992 to establish the Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies. The Committee's charge was to: (1) consider the ethical and legal implications of including women, particularly pregnant women and women of childbearing potential, in clinical studies; (2) examine known instances of litigation regarding injuries to research subjects [End Page 55] and describe existing legal liabilities and protections; and (3) provide practical advice on these issues for consideration by NIH, institutional review boards (IRBs), and clinical investigators.The 16 Committee members came from diverse backgrounds: bioethics, law, epidemiology and biostatistics, public health policy, obstetrics and gynecology, clinical research, pharmaceutical development, social and behavioral sciences, and clinical evaluative sciences.1 Chaired by two of the authors of this article, Ruth Faden and Daniel Federman, and coordinated by the third, IOM Study Director Anna Mastroianni, the Committee met five times over a fourteen-month period, convened a one-and-one-half day invitational workshop, and commissioned several background papers. The Committee's deliberations were complicated by the announcement of new federal policies late in its term. Specifically, the Food and Drug Administration (FDA) issued guidelines (FDA 1993) to replace its 1977 guidelines, which prohibited the inclusion of women of childbearing potential in early phases of most clinical drug trials. In addition, Congress passed the NIH Revitalization Act of 1993 (P.L. 103-43), which contains provisions mandating the inclusion of women and racial and ethnic minorities in NIH-sponsored clinical research. In February 1994, the IOM Committee publicly issued its final report and recommendations, Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, publishing the workshop presentations and commissioned papers in a separate volume.Deliberations of the CommitteeA number of issues arose at the outset as the Committee considered its charge. A few members initially believed that verification of the underrepresentation of women relative to men in clinical studies as a whole was a prerequisite to providing policy recommendations. Others believed that such an examination would be an important contribution to the knowledge base, but that it was not necessary for addressing the Committee's charge. As summarized in the Committee's report, the Committee's research indicated that firm conclusions about the relative underrepresentation of women could not be drawn from the available data because of the lack of systematic information... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:At the Vortex of Controversy:Developing Guidelines for Human Embryo ResearchRonald M. Green (bio)Because of the unavoidable time delay between the submission and publication of this article, its readers will have a significant advantage over its writer: You will know whether the recommendations of the Report of the Human Embryo Research Panel, on which I have served as a member since its inception in January of this year, are (...) progressing smoothly as the basis for evaluating future, federally-funded embryo research—or whether any of the recommendations has become stalled in controversy and political dispute. Staid journals like Science already are predicting that the Panel's Report is likely to create a stormy autumn for the National Institutes of Health.The Panel formally presented its Report to NIH Director Harold Varmus on September 27. The Panel's recommendations will be reviewed by the Advisory Committee to the Director (ACD) until the ACD's next meeting in early December. At that time, the ACD will make formal recommendations to Dr. Varmus, who then will initiate the process of drafting federal regulations that could go into effect by Spring 1995.Historical BackgroundControversy is not new to the area of human embryo research. In the United States, federal regulations enacted in the mid-1970s required any research on the human embryo to be approved by a federally mandated Ethics Advisory Board (EAB). The EAB drafted a significant report that provided ethical guidelines for research on the early, ex utero, human embryo. However, before the report could be acted upon, a new administration, which was opposed to abortion and anything remotely viewed as threatening to prenatal life, came to office, and when the EAB's charter expired in 1980, it was not renewed. In this manner, the Reagan and Bush administrations forestalled any federal support for embryo research in the United States. The next 13 years saw a significant expansion of infertility services in this country, but in the absence of federal funding and [End Page 345] review, there was very little systematic research on either infertility procedures or the human embryo.In January 1993, the U.S. political environment changed again when the Clinton administration fulfilled a campaign promise to remove a nearly five-year-old ban on fetal tissue transplantation research. Although fetal tissue research, which uses the remains of an aborted fetus, significantly differs from embryo research, which involves the developing conceptus ex utero before its transfer to and implantation in a womb, the changed political environment stimulated public discussion of embryo research as well. As a result, in June 1993, Congress nullified the federal regulations requiring EAB review for embryo research. Although this presumably left NIH free to fund embryo research without restrictions, NIH officials felt that guidelines were needed to ensure that such research was conducted in an ethically and socially responsible manner. Accordingly, in January 1994, NIH formed the Human Embryo Research Panel to propose such guidelines.The Panel Begins its WorkChaired by Steven Muller, President emeritus of the Johns Hopkins University, the Panel's 19 members included 7 basic and clinical scientists, 4 ethicists, 2 lawyers, and 6 individuals representing various backgrounds relevant to the making of public policy. Patricia King of the Georgetown University Law Center and Brigid Hogan, a cell biologist at Vanderbilt University, were appointed policy and science co-chairs respectively. Meeting for the first time in early February, the Panel was told by its chair and co-chairs that NIH's need for guidance in the face of pending proposals meant that it had approximately six months—including five one- to two-day meetings each month in Washington—in which to complete its work.In his charge, Dr. Varmus asked the Panel to place the possible areas of research into three categories: (1) acceptable for federal funding; (2) warranting additional review; and (3) unacceptable for federal support. In addition, he asked the Panel to draft guidelines for the review and conduct of the research deemed acceptable.Looking back after months of work, I vividly recall a sense of the enormity of the task facing us. We were being asked, in a short period of time, not only to master... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Protecting Human Research SubjectsThe Office for Protection from Research RisksJoan Paine Porter (bio)The office for Protection from Research Risks (OPRR), located within the National Institutes of Health, has two divisions: Human Subject Protections and Animal Welfare. This article will address the overall responsibilities and current projects relating to human subject protections.OPRR implements the Department of Health and Human Services' (HHS) regulations for the protection (...) of human subjects (45 CFR 46 (1991)). These regulations fulfill the responsibilities set forth in the Public Health Service (PHS) Act with regard to institutional review boards (IRB) and other protections for human subjects involved in biomedical and behavioral research conducted or supported by HHS. The PHS Act also mandates a program to clarify ethical issues in biomedical research involving human subjects and to address violations of the rights of human subjects of research (P.L. 99-158 (1985)).OPRR staff negotiate assurances of compliance with institutions conducting Federally-supported research involving human subjects. The assurances describe the policies and procedures each institution will follow to fulfill the requirements of the regulations, including specific IRB composition and functions.In addition, OPRR cosponsors with the Food and Drug Administration and awardee institutions a series of regional workshops that address human subject protections issues. These are attended by IRB members, institutional officials, research investigators, and others involved with human subject protections.Current ActivitiesNumerous activities are underway in OPRR. The following describes only a few of the initiatives and studies aimed at helping develop policies and procedures to protect human subjects of research."Points to Consider" DocumentsOPRR is currently working with the National Center for Human Genome Research (NCHGR) to develop a "points to consider" document for IRBs and others involved in large genetic pedigree studies. Many questions have emerged [End Page 279] on topics such as how subjects should be recruited, with whom information should be shared about others in the family, social risks of disclosure in employment and insurance, the circumstances and timing of informing subjects about study results, and involvement of children. OPRR and NCHGR hope to assemble a group this fall to review and refine the points that are now being developed jointly. A conference in South Carolina organized by the American Association for Advancement in the Sciences entitled "Project on the Ethical and Legal Implications of Genetic Testing," helped generate advice, and identified some of the more controversial issues in design and conduct of genetic research that involves large groups of family members.Another "points to consider" effort concerns enrollment of women and minorities in research. The PHS has established a policy that members of these groups must be included in research projects unless there are valid scientific justifications for their exclusion which can be made on a project by project basis (ADAMHA/NIH Policy 1990; NIH/ADAMHA Policy 1990). OPRR has commissioned several scholarly papers to help in developing "points to consider" for IRBs as they balance issues of equitable selection of subjects and protection of these selected individuals. Concerns about enrolling women of childbearing age in research that may be harmful to a fetus, and liability issues frequently dominate discussion in this area. The papers will address ethical, legal, and statistical aspects of enrollment of minorities and women as well as provide a description of various practices and roles of IRBs in addressing goals of fair selection of participants and appropriate protections.OPRR is also working with the PHS Panel on Women, Adolescents and Children to produce a document, also in the form of "points to consider" guidance, concerning enrollment of children who are wards of the state in HIV-related research. Subpart D of the regulations for the protection of human subjects (45 CFR 46) specifically addresses research involving children who are wards of the state, including the special protections that must be provided. State and local officials who have authority to enroll foster care children in research have indicated a desire to obtain advice in this area.The IRB GuidebookA major project that is now being completed under contract to the Poynter Center at Indiana University is the IRB Guidebook. It will revise and expand the current IRB Guidebook produced in the 1980s... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Clinical Bioethics at NIH:History and A New VisionJohn C. Fletcher (bio)On July 3, 1995, Dr. John I. Gallin, Director of the Magnuson Clinical Center of the National Institutes of Health (NIH), convened a one-day "Conference on the Future of Clinical Bioethics at the National Institutes of Health Intramural Program." Conferees included NIH officials and a panel of consultants from bioethics programs around the nation.1 The subject was (...) the future of NIH's intramural bioethics program and specifically a vision of a new multi-component program, presented by Dr. Gallin, the first speaker. Dr. Harold Varmus, Director of NIH, was there to assure his support for Dr. Gallin's vision. This author, honored to be second speaker, was invited to sketch a brief history of bioethics at NIH. The present article reviews some of this history and then reports on Dr. Gallin's proposal, points of consensus among speakers and conferees, and the search for a Chief of the Clinical Bioethics Program.History of Bioethics at NIHIt is often said that NIH is a well-kept secret as the nation's leading biomedical research facility. Also, few people know that NIH has a long history in bioethics. Some key events in that history are shown in Figure 1, beginning with two that occurred prior to the birth of bioethics. NIH made an early policy response to protect human subjects of research and to find acceptable limits for scientific freedom. The Clinical Center (CC), a 550-bed research hospital, opened in 1953. A subcommittee of the Medical Board, the Clinical Research Committee (CRC), was formed for prior group review of all studies with normal volunteers. The traditional practice was for researchers themselves to decide when studies would begin, which subjects to recruit, and whether informed consent would be sought. The CRC intervention bit into this tradition. In addition, patient studies that posed significant risks or departed widely from medical practice were reviewed by referral from the Clinical Directors of the various Institutes. Was this CRC an early institutional review [End Page 355] board (IRB)? As a guest researcher, I was permitted to observe the CRCs meetings between 1966 and 1969. It functioned much like an IRB but had no community or non-scientist members. Other IRB-like review groups undoubtedly existed prior to the CRC. Robert Levine (personal communication, September 7, 1995) recalls that Beth Israel Hospital in Boston had one in 1938. Historical research is clearly needed on the earliest forms of research review.Table 1. Bioethics at NIHEventYearClinical Research Committee1953Surgeon-General's PPO #1291966NIGMS funds Hastings Genetics Group1973OPRR's Mission1974NLM's grant to KennedyInstitute for Bibliography of Bioethics1974Recombinant DNA Advisory Committee1974STEP Series Bioethics Speakers1975Pre-IRBs at the CC1975-76Assistant for Bioethics to Director, CC1977RAC-Human Gene Therapy Subcommittee1983Lipsett Proposal (ICD)1983Liaison Group, CC1983Bioethics Program, CC1985Durable Power of Attorney for Researchwith Incapacitated Subjects1985-86NLM funds National Reference Centerfor Bioethics Literature1985National Institute for Nursing Research1986Bioethics Post-Doctoral Fellows Program1989ELSI Program1989Bioethicists on CC-IRBs1989CC-Ethics Committee1990Office of Human Subjects Research1992 [End Page 356]Between 1963 and 1967, the media exposed instances of ethically troubling research, and Beecher (1966) and Pappworth (1967) published sharp criticisms of the weak state of research ethics. In 1966, Surgeon-General William Stewart and NIH Director James Shannon issued a policy requiring local group review of all research involving human subjects before making an application for NIH peer review (Surgeon General 1966). The policy was the first in any nation to mandate ethics committees for clinical research. However, it did not apply to the NIH intramural program until Congress passed the National Research Act in 1974 (Public Law 93-348; 202, 88 Stat. 342, 1974). This lag permitted NIH intramural investigators the luxury of feeling above the norms imposed on ordinary mortals and guaranteed more resistance to the inevitable change to come. Resistance to change marked the intramural program from the mid-1960s to the mid-1970s... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Future Directions for Oversight of Stem Cell Research in the United StatesCynthia B. Cohen (bio) and Mary A. Majumder (bio)Human pluripotent stem cell research, meaning research into cells that can multiply indefinitely and differentiate into almost all the cells of the body, has become a minefield in which science, ethics, and politics have collided over the last decade in the United States. President Barack Obama entered (...) this highly charged territory when he indicated during his campaign that once in office he would issue an executive order expanding federally funded human embryonic stem cell (hESC) research and introduce rigorous oversight of it (Obama 2008a & b). Candidate Obama stated that he would require that the hESC lines involved were derived with donor consent from early embryos that otherwise would be discarded following in vitro fertilization (IVF) treatment. However, in contrast with the policy of President George W. Bush, he would do so without regard to the date of their derivation. He added that he would call upon the director of the National Institutes of Health (NIH) to develop guidelines for federally funded hESC and other pluripotent stem cell research that would draw from the guidelines developed in 2005 by the National Academies of Science (NAS) for privately funded research (National Research Council 2005).A similar policy was written into the 2008 version of the Stem Cell Research Enhancement Act, which reiterates the policy enunciated in earlier versions of this bill, passed twice by the Congress but vetoed by President Bush each time (House of Representatives, 110th Congress 2008).1 Depending on how one reads the 2008 version of the act, it could also apply in certain respects to hESC research that is not federally funded. We proceed on the assumption that the act applies at least to federally funded stem cell research. Therefore, it appears that the president or the Congress, or both, will approve of an expanded policy of federal funding of hESC research, as well as other forms of human pluripotent stem cell research. [End Page 79]This policy would make the guidelines developed by a committee appointed by NAS, a prestigious private body of American scientists and related experts, the primary basis for the development of new federal guidelines for oversight of hESC research in the United States. This would have certain advantages in that those familiar with the relevant scientific issues are likely to address them accurately and stem cell investigators are apt to accept restrictions on their research written by fellow scientists and ethics and policy experts whom they perceive as strong supporters of stem cell research. However, it also would have certain disadvantages. Chief among these is that the NAS committee appointed to write guidelines for this research, in its concern to see stem cell science move forward after a period in which many scientists and others maintained that it had been unduly restricted, might have overlooked or deferred consideration of some pressing ethical and policy issues. We maintain that this is the case—although we also maintain that the NAS guidelines provide a responsible foundation for developing NIH guidelines for stem cell research. Consequently, we propose that an NIH task force charged by the director of NIH with writing new guidelines for hESC and other stem cell research should revise and expand the NAS guidelines in ways that we propose below, as well as others that it considers necessary, and make it obligatory for those seeking federal funding of such research to follow these new guidelines.We highlight certain areas in which an ethical case can be made for strengthening the existing NAS guidelines and certain areas in which more fundamental ethical reflection—and building on that, additional guideline/policy development—seems warranted. Among the sections of the NAS guidelines that need clarification and reworking, we include those regarding consent to embryo donation, which provide one of their central focuses, and the development of human-nonhuman chimeras, which they address relatively briefly. In addition, we maintain that new guidelines need to be written to address the nascent ethical and policy issues raised by the possibility that human gametes will be induced from pluripotent stem cells in the next few years and that... (shrink)

The European Union Data Protection Regulation will have profound implications for public health, health services research and statistics in Europe. The EU Commission's Proposal was a breakthrough in balancing privacy rights and rights to health and healthcare. The European Parliament, however, has proposed extensive amendments. This paper reviews the amendments proposed by the European Parliament Committee on Civil Liberties, Justice and Home Affairs and their implications for health research and statistics. The amendments eliminate most (...) innovations brought by the Proposal. Notably, derogation to the general prohibition of processing sensitive data shall be allowed for public interests such as the management of healthcare services, but not health research, monitoring, surveillance and governance. The processing of personal health data for historical, statistical or scientific purposes shall be allowed only with the consent of the data subject or if the processing serves an exceptionally high public interest, cannot be performed otherwise and is legally authorised. Research, be it academic, government, corporate or market research, falls under the same rule. The proposed amendments will make difficult or render impossible research and statistics involving the linkage and analysis of the wealth of data from clinical, administrative, insurance and survey sources, which have contributed to improving health outcomes and health systems performance and governance; and may illegitimise efforts that have been made in some European countries to enable privacy-respectful data use for research and statistical purposes. If the amendments stand as written, the right to privacy is likely to override the right to health and healthcare in Europe. (shrink)

‘Researcher identity’ affects global health research in profound and complex ways. Anthropologists in particular have led the way in portraying the multiple, and sometimes tension-generating, identities that researchers ascribe to themselves, or have ascribed to them, in their places of research. However, the central importance of researcher identity in the ethical conduct of global health research has yet to be fully appreciated. The capacity of researchers to respond effectively to the ethical tensions surrounding their identities (...) is hampered by lack of conceptual clarity, as to the nature and scope of the issues involved. This paper strives to provide some clarification of these ethical tensions by considering researcher identity from the perspective of (1) Guillemin and Heggen's (2009) key distinction between procedural ethics and ethics in practice, and (2) our own distinction between perceptions of identity that are either symmetrical or asymmetrical, with the potential to shift research relationships toward greater or lesser ethical harmony. Discussion of these concepts is supported with ethnographic examples from relevant literature and from our own (United States (US) Government-funded) research in South Africa. A preliminary set of recommendations is provided in an effort to equip researchers with a greater sense of organization and control over the ethics of researcher identity. The paper concludes that the complex construction of researcher identity needs to be central among the ethical concerns of global health researchers, and that the conceptual tools discussed in the paper are a useful starting point for better organizing and acting on these ethical concerns. (shrink)

A complex network of ethico‐legal rules makes it difficult for health researchers in South Africa to lawfully recruit adolescents to the kinds of sensitive studies where it may be ethically appropriate to proceed without notifying parents or obtaining parental consent. This article responds to a recent proposal to amend the blanket requirement for mandatory parental consent presently contained in section 71 the South African National Health Act 61 of 2003 [NHA]. The proposed amendment is intended to bring the (...) NHA into alignment with South Africa's 2015 Department of Health Guidelines on Ethics in Health Research by permitting greater flexibility for a health research ethics committee to waive parental consent, and permit adolescents to consent independently. A lacuna in this proposal is highlighted with reference to the requirements of South Africa's Protection of Personal Information Act 4 of 2013 [POPIA]: Even if the NHA is amended as proposed, the goal of aligning South African law with prevailing ethics norms in South Africa would not necessarily be attained, as parental consent may still be required by POPIA. This article investigates whether this goal (of aligning the law with ethics) can be attained in a way that is compliant with POPIA. It is concluded that this is indeed possible in a number of ways, and that the best way to attain this goal is by requesting the South African Information Regulator to issue a guidance note to the effect that all health research projects that are approved by institutional health research ethics committees are to be regarded as being in the public interest, which would qualify such health research projects to be exempted from POPIA's consent requirements. (shrink)

There is significant evidence that the health needs of women and minorities have been neglected by a medical research community whose agendas and protocols tend to focus on more advantaged segments of society. In response, the National Institutes of Health and Food and Drug Administration in the United States have recently issued new policies aimed at increasing the utilization of women in clinical studies. As well, the U.S. Congress passed the NIH Revitalization Act of 1993, which specifically (...) mandates increased inclusion of women and racial and ethnic groups in clinical studies. On the face of it, such gender and race-specific policies would appear to be morally problematic because traditionally ethics opposes the use of sex or race as legitimate criteria for distributions of benefits or burdens in social policies. Hence, these policies pose some significant moral questions. Feminist ethics provides us with a framework for evaluating such policies because of its readiness to recognize that socially and politically significant factors such as sex and race are morally relevant in setting public policy. Of course, feminist ethics does not simply endorse all appeals to sex and race but only the policies in which attention to such factors will contribute to social justice. In this essay, I Identify some of the Important ethical questions that a feminist ethics perspective raises about research policies devised to promote the Inclusion of women in clinical studies. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 10.2 (2000) 171-174 [Access article in PDF] Bioethics Inside the Beltway The Oversight of Human Gene Transfer Research LeRoy Walters Jesse Gelsinger's death last September in a gene transfer study being conducted at the University of Pennsylvania has helped to spark a national debate. In part, this debate parallels the broader discussion of how human subjects research should be reviewed and regulated (...) in the United States. However, human gene transfer research is one of a handful of biomedical technologies that seem to deserve special attention, at least in the early years of their development.The major participants in the national debate on human gene transfer include the National Institutes of Health (NIH), the Food and Drug Administration (FDA), the National Bioethics Advisory Commission, members of Congress, biotechnology and pharmaceutical companies, disease-oriented advocacy groups, reporters, and academics. At the December 1999 meeting of the NIH Recombinant DNA Advisory Committee (RAC), the protocol that involved Jesse Gelsinger was a central focus of discussion, but other topics emerged as well. One ad hoc panel reviewed adverse events that had occurred in other research protocols using adenovirus vectors, while a second proposed changes in the general system for reporting adverse events to NIH and the RAC.During the first several months of the year 2000, the United States Congress also became involved in the human gene transfer debate. In February, Senator Bill Frist (R-TN) convened a hearing to which Jesse Gelsinger's father, representatives of NIH and FDA, and several other witnesses were invited. At approximately the same time, the House Commerce Committee and its Subcommittee on Oversight and Investigations initiated their own inquiries, asking the Office of Inspector General at the Department of Health and Human Services to review the oversight roles of NIH and FDA. In March and April, the House committee also wrote directly to the NIH Director, the FDA Commissioner, and the President of the University of Pennsylvania, requesting extensive documentation on gene transfer, in general, and the trial in which Jesse Gelsinger was involved, in particular. Congressman Henry Waxman (D-CA) and Senator Edward Kennedy (D-MA) have also raised questions and proposed solutions in multiple letters to the NIH Director and the Secretary of Health and Human Services. [End Page 171]The major general questions that have emerged from this discussion are the following:(1) What kinds of information about adverse events should be reported by researchers or sponsors during the course of human gene transfer trials?(2) To what group or groups should adverse-event information be reported? How often and in what ways should the information be analyzed?(3) Should the information about adverse events remain confidential, or should it be discussed publicly?(4) How can the disclosure and consent process in gene transfer trials be improved?(5) Which federal agency should have primary responsibility for overseeing human gene transfer research, and how can it best fulfill its oversight role?How these questions are answered will have immediate relevance to the field of human gene transfer research as it enters into its next phase. At the same time, the models that are created for this important cutting-edge field also may be useful in other complex or controversial arenas of biomedical research, for example, xenotransplantation or human embryonic stem-cell research. In addition, the lessons learned from this one important area of human subjects research may suggest ways to improve protections for all the volunteers who make clinical research--and medical progress--possible.In the remainder of this article, I will turn from reporting, in as objective a way as possible, on the status of the public policy debate about human gene transfer research to suggesting measures for improving the current oversight system for such research. My initial general recommendation is that we should not expect a single regulatory agency to be solely responsible for a field as large and dynamic as human gene transfer research. Rather, there should be some helpful redundancy or, to change the metaphor, checks and balances in the public oversight of this field. Thus, an... (shrink)

The ethics of benefit sharing has been a topical issue in global health research in resource-limited countries. It pertains to the distribution of goods, benefits and advantages to the research participants, communities and countries that are involved in research. One of the nuances in benefit sharing is the ethical justification on which the concept should be based. Extensive literature outlining the different principles underlying benefit sharing is available. The purpose of this paper is to examine the (...) proposed principles using Aristotelian principles of justice. The paper assesses the central idea of Aristotelian justice and applies and evaluates this idea to benefit sharing in research, especially when commercial research sponsors conduct research in resource-limited countries. Two categories of Aristotelian justice—universal and particular—were examined and their contribution to the benefit-sharing discourse assessed. On the one hand, benefit sharing in accordance with universal justice requires that for-profit research sponsors obey the legal regulations and international standards set for benefit sharing. On the other hand, benefit sharing in accordance with particular justice transcends obeying legal requirements and standards to a realm of acting in an ethically accepted manner. Accordingly, the paper further examines three perspectives of particular justice and develops ethical justification for benefit sharing in global health research. As Aristotelian justice is still relevant to the contemporary discourse on justice, this paper broadens the ethical justifications of benefit sharing in global health research. (shrink)

Scientists, bioethicists, and policy makers are currently engaged in a contentious debate about the scientific prospects and morality of efforts to increase human longevity. Some demographers and geneticists suggest that there is little reason to think that it will be possible to significantly extend the human lifespan. Other biodemographers and geneticists argue that there might well be increases in both life expectancy and lifespan. Bioethicists and policy makers are currently addressing many of the ethical, social, and economic issues raised by (...) life extension research. However, the emphasis on philosophical argument supporting or condemning efforts to increase human longevity means that much less attention is currently being given to the factors that might play a role in generating interest in efforts to increase human longevity. This analysis considers three factors that might play a role in heightening public interest in efforts to develop biomedical technologies capable of retarding or reversing aging processes. While discussions of life extension research can seem quite futuristic and impractical, there are some powerful existential factors that might well generate considerable public support for life extension strategies if effective biomedical interventions emerge. Rather than providing philosophical justifications supporting or condemning efforts to increase human longevity, this essay seeks to promote a better understanding of the factors generating contemporary interest in prolonging life and postponing death. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The Office of Scientific IntegrityDavid P. Hamilton (bio)For most of the 1980s, the specter of scientific fraud popped into public view every few years, usually only to submerge again. Faced with several well-publicized cases of scientists who blatantly faked their data—among the best-known being Harvard cardiologist John Darsee (whose colleagues watched him forge data) (Broad and Wade 1982, p. 14) and Sloan-Kettering Institute immunologist William Summerlin (who painted black (...) spots on white mice to simulate tissue grafts) (Broad and Wade 1982, p. 155)—the scientific community as a whole tended to dismiss the phenomenon as the work of a few deviants. Called in 1981 to testify before then-Representative Albert Gore Jr.'s subcommittee on investigations and oversight, Philip Handler, then-president of the National Academy of Sciences, told the panel that science was perfectly capable of regulating itself, and that the problem of scientific fraud had been "grossly exaggerated" by the press (Broad and Wade 1982). The message was clear: Congress should stick to its knitting, and science would take care of itself.Now, however, scientists are faced with a very different situation: a permanent federal bureaucracy, known as the Office of Scientific Integrity (OSI), devoted to the investigation of alleged scientific wrongdoing. The transition from the days of laissez-faire, when universities were entrusted with all investigations unless they were handled so badly that the federal government was forced to take notice, has been an uncomfortable one for many researchers. Lately, this discomfort has taken shape as a vocal protest against OSI. Largely as a result of this protest, federal officials recently promoted a plan to restructure OSI and change some of its operating procedures, a move with unpredictable consequences for universities and researchers alike.OSI was born largely because of investigations by two influential congressmen: Representatives John Dingell of Michigan and Ted Weiss of New York. While both claimed they acted mainly to make sure taxpayer dollars were not spent on fraudulent research, both also maintained a strong interest in protecting "whistleblowers," the often vulnerable, and usually junior, scientists who first raise questions about bad research. And Dingell seemed to take special pleasure in pointing up the deficiencies of investigations run by universities and by the National Institutes of Health (NIH) itself. (For reasons that are not well understood, [End Page 171] biomedical research seems far more prone to fraud than any other field of science. As a result, NIH, which funds most biomedical research in the United States, has held ultimate responsibility for most prominent cases of fraud.) Plagued as they often were by conflicts of interest, shoddy methodologies, and, in some cases, a willingness to believe any excuse by the accused, no matter how far-fetched, these investigations made easy targets. And the notion that science could "govern itself" grew harder to sustain.In late 1988, Dingell and other congressmen began circulating draft bills that would have created a new office for investigating scientific fraud. Dingell would have placed such an office under the aegis of the Inspector General of the Department of Health and Human Services, raising the possibility that scientific fraud might be probed by the same criminal investigators who unravel Medicare fraud. Unsettled by this vision of the "science police," NIH officials moved quickly to pre-empt Congress. On March 16, 1989, they published a notice in the Federal Register announcing the creation of OSI, an office with responsibility for ensuring thorough university investigations of misconduct and the authority to conduct its own investigations when necessary.From the beginning, OSI took an unusual approach to its work. For one thing, the office had a broad mandate: Although located within NIH, it was responsible for research funded throughout the entire Public Health Service, including the Food and Drug Administration, the Alcohol, Drug, and Mental Health Administration, and the Centers for Disease Control. Furthermore, it was not restricted to scientific fraud. Departmental lawyers, wishing to avoid the legal connotations of the term "fraud"—in particular, a requirement that fraudulent actions not only mislead others but also cause them noticeable harm—decided instead to adopt the term "scientific misconduct," defined as "fabrication, falsification, plagiarism, or other practices that deviate... (shrink)

Without trust there is no credible human health research (HHR). This article accepts this truism and addresses a crucial question that arises: how can trust continually be promoted in an ever-changing and uncertain HHR environment? The article analyses long-standing mechanisms that are designed to elicit trust—such as consent, anonymization, and transparency—and argues that these are best understood as trust represented by proxies of trustworthiness, i.e., regulatory attempts to convey the trustworthiness of the HHR system and/or its actors. Often, (...) such proxies are assumed to operate as markers that trust exists or, at least, has not been lost. But, since trust can neither be “built” nor “secured,” this is a precarious assumption. Worryingly, there is no existing theoretical account of how to understand and evaluate these proxies of trustworthiness as part of a trusted HHR ecosystem. To remedy this, the paper argues for a radical reimagining of trust and trustworthiness as performative acts that ought to be understood in relation to each other and by reference to the common values at stake. It is shown that proxies of trustworthiness are the operational tools used to perform trustworthiness. It advocates for a values-based approach to understanding the relationship between trust and trustworthiness. This establishes a strong basis for an evaluative framework for proxies of trustworthiness, i.e., to determine how to perform trustworthiness well. Five common proxies in HHR are scrutinized from a values perspective. The contribution is to provide a far-reaching normative and practical framework by which existing and future proxies of trustworthiness can be identified, assessed, maintained, or replaced in rapidly changing HHR regulatory ecosystems where trust itself is crucial to the success of the entire HHR enterprise. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Future Directions for Oversight of Stem Cell Research in the United States: An UpdateMary A. Majumder (bio) and Cynthia B. Cohen (bio)On 9 March 2009, President Barack Obama (2009a) signed an executive order revoking the statement issued by President George W. Bush during a televised speech in August 2001, in which the latter had sharply restricted the scope of federally funded human embryonic stem cell (hESC) research (...) to cell lines derived (without federal funding) prior to 9:00 P.M. EDT on 9 August 2001. Action by President Obama to remove the cut-off date had been expected. It came as a surprise, however, that he gave authority to determine the scope of eligible research to the Director of the National Institutes of Health (NIH), referencing only general concerns of responsibility, scientific worth, and legality.1 This contrasted not only with the approach of former President Bush, but also with that of former President Clinton, who had expressed personal opposition to the creation of embryos for research and had a distinction between hESCs derived from embryos created for research and those derived from spare embryos enshrined in NIH policy.President Obama’s remarks upon signing the executive order give some insight into the thinking behind his approach. Implicit in them are the views that earlystage human embryos outside the womb do not have full moral status and that the destruction of human embryos in the effort to care for and ease the suffering of human beings who do have full moral status does not devalue human life. The President also stressed that the decision to pursue hESC research reflected not only his opinion, but also a broad social consensus. He concluded with strong ethical commitments on two fronts:We will develop strict guidelines, which we will rigorously enforce, because we cannot ever tolerate misuse or abuse. And we will ensure that our government never opens the door to the use of cloning for human reproduction. It is dangerous, profoundly wrong, and has no place in our society, or any society.(Obama 2009b)The specific guarantee that President Obama gave against government support for the development of cloning techniques for human reproductive purposes made his silence on the use of cloning for research seem significant. Comments he had made in the course of the campaign (Obama 2008) suggested that he would affirm [End Page 195] the Clinton-era policy of limiting federal funding to hESCs derived from spare embryos. Did this silence mean that President Obama was opening the door to federal funding of research cloning when and if scientists might manage that feat?2009 NIH GuidelinesThe answer to this question and several others came on 17 April, when Raynard Kington, the acting director of NIH, released Draft NIH Guidelines for Human Stem Cell Research (NIH 2009), developed by an NIH Stem Cell Task Force, along with a request for public comment within 30 days of their publication in the Federal Register.2 The 2009 Draft Guidelines exclude from federal funding the derivation of hESCs, a restriction mandated by the reenactment of the Dickey-Wicker Amendment as part of the 2009 Omnibus Appropriations Act (Public Law 111-8, Division F, Title V, § 509). The 2009 Draft Guidelines also exclude the use of hESCs derived from embryos created for research purposes, and so represent a refusal to open the funding door as broadly as the NIH interpretation of the Dickey-Wicker Amendment might allow, at least for the time being.It appears that the drafters used as their starting point the 2000 NIH Guidelines for Research Using Human Pluripotent Stem Cells (NIH 2000) dating from the Clinton Administration, rather than more recent guidelines from the National Academy of Sciences (National Research Council 2005; 2007; 2008) and other private bodies. Both the format and content of the 2000 and 2009 NIH efforts are similar, making the departures in the latter stand out in high relief. We highlight departures related to informed consent to embryo donation, creation of human-nonhuman chimeras, and the role of an NIH task force, updating our original comment (Cohen and Majumder 2009).Informed Consent to Embryo DonationThe 2009 NIH Draft Guidelines require that certain statements... (shrink)

Photo ID 71252867© Stepan Popov| Dreamstime.com Abstract While Medical Assistance in Dying (MAiD) has been legalized in Canada since 2016, it still excludes eligibility for persons who have mental illness as a sole underlying medical condition. This temporary exclusion was set to expire on March 17th, 2024, but was set 3 years further back by the Government of Canada to March 17th, 2027. This paper presents a critical appraisal of the case of MAiD for individuals with mental illness as the (...) sole underlying medical condition through the analysis of three ethical theories: principlism, deontology, and utilitarianism. Through evidence and discussion, it will be demonstrated that MAiD, in this context, may be ethically justifiable on the grounds of upholding human rights, protecting dignity, and minimizing suffering. Introduction In June of 2016, Medical Assistance in Dying (MAiD) was legalized in Canada.[1] Throughout the first six years, a temporary exclusion of eligibility for persons suffering solely from mental illness was extended.[2] The exclusion of mental illness as a sole underlying medical condition was set to expire on March 17, 2024.[3] However, on February 1, 2024, just over a month before the set expiration, the Government of Canada once again extended the exclusion, this time setting it back three years to March 17, 2027. There are currently several countries that allow MAiD for mental illness, including Belgium, the Netherlands, and Luxembourg.[4] Some countries, like Spain,[5] do not give specific guidance, leaving the matter under discussion by ethicists and courts. In these countries, there are specific (although different) requirements for the process; overall, for mental illness, the illness must be verifiable and not simply related to a perception of satisfaction with the length of life. This extension ignited discussion on whether MAiD for persons who have mental illness as a sole underlying medical condition in Canada is ethically acceptable. As a complex, multi-faceted, and interdisciplinary issue, ethicists assessing MAiD must take into account various moral obligations and considerations. This paper analyses MAiD in this context through the application of three ethical theories: principlism, deontology, and utilitarianism. This paper concludes that, based on the current evidence and knowledge of this developing situation, MAiD for persons with mental illness in Canada may be ethically justified on the grounds of upholding human rights, labour obligations, and dignity. Through the exploration of research and discussions, it will be demonstrated that society at large ought to protect liberty and act towards relieving suffering, thereby supporting the potential eligibility of MAiD for persons who have mental illness. Principlism: The Capacity and Ability to Assess and Decide for One’s Own Life Principlism is the application of four principles: autonomy, beneficence, non-maleficence, and justice. Principlism supports permitting MAiD for mental illness due to the importance of autonomy in decision-making, equitable and just practices for MAiD assessors, and reducing suffering for patients and their family member(s) and/or friend(s). Carter v. Canada, the Canadian Supreme Court ruling of 2015—which changed Canadian law to allow for MAiD—held that the prohibition of MAiD infringed on Canadians’ right to “life, liberty, and the security of the person.” In a unanimous decision, the Supreme Court of Canada decided that the criminal prohibition of MAiD violates the Canadian Charter of Rights and Freedoms.[6] The Court concluded that the criminal law prohibiting MAiD interfered with people’s autonomy and dignity, which are protected by the rights of liberty and security of the person.[7] The ruling emphasized that Canada’s constitution reflects the fundamental importance of individual autonomy in personal decision-making. Research provides evidence that MAiD improves autonomy: A study among psychiatric patients found that 8 of 48 psychiatric patients said the mere option of accessing MAiD was enough to assess their future options for living wholly.[8] These findings complement a study entailing interviews with 30 adults who have mental illness, which emphasized that the ability to access MAiD allows individuals to analyze their quality of life, envision their desired future, and make decisions accordingly.[9] Although not all participants agreed that mental illness as the only underlying medical condition was appropriate for MAiD eligibility, many participants agreed that patient autonomy in decision-making was paramount and should be respected. However, autonomy as an ethical principle does not immediately grant all persons with mental illness the option to access MAiD. There are multiple eligibility criteria for those who wish to receive MAiD, which still must be approved and assessed. Currently, eligibility criteria for MAiD states that individuals must “give informed consent to receive MAiD, meaning that the person has consented to receiving MAiD after they have received all information needed to make this decision.”[10] Consent requires capability or capacity, which is the ability to understand relevant information, appreciate its potential consequences, and make an informed decision for oneself.[11] Like for many other diseases, disabilities, and conditions, patient capability is determined on a case-by-case basis.[12] Given the stigma surrounding those struggling with mental health, this thorough case-by-case examination of an individual patient’s capability and capacity without prejudice or partiality should lead to equitable and fair treatment. Without appropriate testing, those with mental illness could be wrongly stripped of their decision-making power. Arguments against MAiD for those with mental illness have raised concerns about the potential for individuals to harm themselves and others. A survey of MAiD providers demonstrated that physicians believed that the bereavement experience following MAiD is challenging and profoundly distinct and that bereavement support for all members involved should be required.[13] However, while watching one die (of MAiD) may cause harm to their families, friends, and support system at large, it is also important to recognize that watching someone suffer and struggle through their mental health journey also poses significant harm. Qualitative studies in Ontario, Canada, have interviewed family members of persons with mental illness as a sole medical condition, and interviewees shared that witnessing the illness and its impacts on their close one's lives was a very difficult experience.[14] As it relates to MAiD, participants emphasized that those living with mental illness are in the best position to understand their own pain and suffering and, in turn, make their own decisions about relief.[15] In an interview, a MAiD provider stated that MAiD may provide less suffering and more peace, and that, although it “depends on the family,... usually the family is more prepared and at peace.”[16] On the contrary, a person who has mental illness may perceive choosing MAiD as beneficial to their family member(s) and/or friend(s). Among those who died by MAiD in 2021, 35.7 percent reported that they perceived themselves as a burden on their family and friends.[17] While some authors report their concerns regarding such social burden as a potential driving factor for MAiD requests, others report that there are other additional burdens associated with requesting MAiD that may be financial, societal, and personal.[18] As such, the extension of MAiD eligibility to those with mental illness will likely only allow a small number of people to be granted MAiD.[19] Many others will be diverted to appropriate services and treatments. Patients’ decision to choose MAID noted their ability to make choices about their own care, reflecting the value of autonomy.[20] Although it is difficult to determine what is good for families in individual cases, MAiD presents an option that is both beneficent and non-maleficent. Therefore, these arguments satisfy the principles which do not necessarily conflict with MAiD. Deontology: The Duty to Recognize Vulnerability and Relieve Suffering The argument here begins with the fundamental focus of deontology—that moral duty lies in an action rather than in its consequences. Further discussion is required to analyze the impact of MAiD on healthcare workers. The Canadian Medical Association (CMA) Code of Ethics and Professionalism requires physicians to abide by virtues, commitments, and responsibilities in delivering health care and service.[21] The code states that “a compassionate physician recognizes suffering and vulnerability, … and alleviate[s] the patient’s suffering.”[22] In the context of MAiD for persons with mental illness as a sole underlying medical condition, vulnerabilities could be wide in range. Many Canadians are concerned with the interaction between mental health and other social determinants of health, such as the lack of medical, disability, financial, housing, and social support and resources.[23] As a result, another layer to the ethical issue arises: Does permitting MAiD for mental illness treat the symptoms of the issue rather than the root problem itself (social, economic, and systemic inequities)? Some argue against MAiD, stating that the nation should first focus on developing better quality care and service.[24] Others support MAiD as a potential harm reduction approach, given that most of these unjust conditions require a higher level of long-term structural and public policy overhaul.[25] The CMA Code also calls upon physicians to recognize and alleviate patients’ suffering. Some argue that while physicians and medical professionals do work to relieve suffering, they are trained to do so through a primary care-based diagnose-and-treat approach.[26] Studies that have captured Canadian physicians’ experiences providing MAiD report that, although physicians stated that the work was rewarding, it came with many challenges, including strained relationships with coworkers, increased workload, and inadequate compensation.[27] Physicians report that a part of the problem is that MAiD rules are written by lawyers and experts who are removed from its reality in medical practice. As a result, there is a lack of clarity surrounding practice norms and a lack of support for physicians.[28] Thus, while healthcare practitioners have a duty to relieve patients’ suffering, they should feel adequately trained and supported in doing so. If physicians and healthcare professionals recognize vulnerability and relieve suffering, then they should act accordingly, regardless of potential associations or outcomes. Making persons with mental illness eligible for MAiD ensures that treatment to relieve their suffering is available. However, it is imperative that there are sufficient resources and support available to healthcare professionals to ensure that they feel prepared and supported to provide MAiD, should they wish to do so. Utilitarianism: Minimizing Intolerable Suffering and Dying with Dignity Overall, utilitarianism is largely concerned with the greatest happiness principle—to increase the amount of happiness for the greatest number of people. So far, this paper has analyzed individual, family, and practitioner-based ethical considerations. But if MAiD were to be extended to those with mental illness as a singular underlying medical condition, what implications would this have for the world and society at large? There is a global drive toward authorizing organized ending of life, with an increasing number of countries legalizing MAiD.[29] The medical system is generally seen as a safe and appropriate system to carry out MAiD, especially when suicide and self-harm are regarded as “alternatives.” Yet despite these worldwide efforts, many argue through the theory of utilitarianism that the inability to see long-term consequences renders MAiD a premature solution, particularly for those who are unable or unwilling to seek other forms of potentially healing treatment or for those who may undergo MAiD only for a technological innovation or biomedical advancement to later come along as a potential cure.[30] While it is true that MAiD does not prevent these “premature deaths,” it is also true that it does not claim to.[31] MAiD provides an option to alleviate intolerable suffering. Some individuals with severe mental illness do describe their condition as intolerable suffering. MAiD is seen as an option to minimize suffering. It can also be seen as a way to die with dignity and relief.[32] While predicting outcomes is difficult, extending MAiD eligibility for persons experiencing mental illness does not undermine its ability to end suffering. It allows eligible individuals to take charge of their health, their life, and their future. Conclusion Based on the current evidence, allowing MAiD for persons with mental illness as their sole underlying medical condition presents as an ethically justifiable action. The right to self-determination and fair accessibility demonstrates that there is more harm done by prohibiting MAiD for mental illness than allowing it. Such liberty is a right, and in the context of relieving suffering, it is a duty that healthcare workers must uphold, although the ability to opt out of providing MAiD is well established. Thus, to recognize vulnerability and relieve suffering means to provide methods, such as MAiD, for those deeply impacted by mental illness. These justifications stand at both the individual level and for society at large. Nevertheless, it remains imperative to take an upstream approach that addresses the social determinants of health and aims to prevent mental illness and promote long-term, beneficial social change for those suffering, struggling, and vulnerable in our communities. - [1] Jaro Kotalik and David W. Shannon, Medical Assistance in Dying (MAID) in Canada Key Multidisciplinary Perspectives, 1st ed. 2023., The International Library of Bioethics, 104 (Cham: Springer International Publishing, 2023), https://doi.org/10.1007/978-3-031-30002-8. [2] Department of Justice Government of Canada, “Canada’s Medical Assistance in Dying (MAID) Law,” February 21, 2024, https://www.justice.gc.ca/eng/cj-jp/ad-am/bk-di.html. [3] Health Canada, “Final Report of the Expert Panel on MAiD and Mental Illness,” transparency - other, May 13, 2022, https://www.canada.ca/en/health-canada/corporate/about-health-canada/public-engagement/external-advisory-bodies/expert-panel-maid-mental-illness/final-report-exp ert-panel-maid-mental-illness.html. [4] Federal Public Service (FPS) Health Belgium, “Federal Commission for the Control and Evaluation of Euthanasia,” n.d., https://consultativebodies.health.belgium.be/en/advisory-and-consultative-bodies/federal-commission-control-and-evaluation-euthanasia .; Government of Netherlands, “Is Euthanasia Allowed in the Netherlands?,” n.d., https://www.government.nl/topics/euthanasia/is-euthanasia-allowed.; “Information on Requesting Euthanasia or Assisted Suicide,” n.d., https://guichet.public.lu/en/citoyens/sante/fin-vie/euthanasie/euthanasie-assistance-suicide.html. [5] Luis Espericueta, First official report on euthanasia in Spain: A comparison with the Canadian and New Zealand experiences, Medicina Clínica (English Edition), Volume 161, Issue 10, 2023, Pages 445-447, ISSN 2387-0206, https://doi.org/10.1016/j.medcle.2023.06.021. [6] Government of Canada, “The Canadian Charter of Rights and Freedoms,” March 15, 2021, https://www.justice.gc.ca/eng/csj-sjc/rfc-dlc/ccrf-ccdl/. [7] Supreme Court of Canada, “Carter v. Canada,” Constitutional Law, 2015, https://scc-csc.lexum.com/scc-csc/scc-csc/en/item/14637/index.do.; Kotalik and Shannon, Medical Assistance in Dying (MAID) in Canada Key Multidisciplinary Perspectives. [8] Karandeep Sonu Gaind, “What Does ‘Irremediability’ in Mental Illness Mean?,” Canadian Journal of Psychiatry. Revue Canadienne de Psychiatrie 65, no. 9 (September 2020): 604–6, https://doi.org/10.1177/0706743720928656; Lieve Thienpont et al., “Euthanasia Requests, Procedures and Outcomes for 100 Belgian Patients Suffering from Psychiatric Disorders: A Retrospective, Descriptive Study,” BMJ Open 5, no. 7 (July 27, 2015): e007454, https://doi.org/10.1136/bmjopen-2014-007454. [9] Hamer Bastidas-Bilbao et al., “Walking Alongside: Views of Family Members on Medical Assistance in Dying for Mental Illness as the Sole Underlying Medical Condition,” Qualitative Health Research 33 (September 29, 2023), https://doi.org/10.1177/10497323231197365. [10] Government of Canada, “Canada’s Medical Assistance in Dying (MAID) Law.” [11] Commission sur les soins de fin de vie, “Les conditions de l’admissibilité à l’aide médicale à mourir au Québec: la constance dans l’évolution de la loi concernant les soins de fin de vie,” June 9, 2023, https://csfv.gouv.qc.ca/ fileadmin/docs/autres_rapports/csfv_lcsfv_conditions_ amm_2023-06-29.pdf.; Trudo Lemmens, “When Death Becomes Therapy: Canada’s Troubling Normalization of Health Care Provider Ending of Life,” The American Journal of Bioethics 23, no. 11 (November 2, 2023): 79–84, https://doi.org/10.1080/15265161.2023.2265265. [12] Justine Dembo, Udo Schuklenk, and Jonathan Reggler, “‘For Their Own Good’: A Response to Popular Arguments Against Permitting Medical Assistance in Dying (MAID) Where Mental Illness Is the Sole Underlying Condition,” Canadian Journal of Psychiatry. Revue Canadienne De Psychiatrie 63, no. 7 (July 2018): 451–56, https://doi.org/10.1177/0706743718766055. [13] Konia Trouton et al., “Attitudes and Expectations Regarding Bereavement Support for Patients, Family Members, and Friends: Findings from a Survey of MAID Providers,” British Columbia Medical Journal 62, no. 1 (2020). [14] Bastidas-Bilbao et al., “Walking Alongside.” [15] Bastidas-Bilbao et al. [16] Trouton et al., “Attitudes and Expectations Regarding Bereavement Support for Patients, Family Members, and Friends: Findings from a Survey of MAID Providers,” 2020. [17] Ramona Coelho et al., “The Realities of Medical Assistance in Dying in Canada,” Palliative & Supportive Care 21, no. 5 (October 2023): 871–78, https://doi.org/10.1017/S1478951523001025; Health Canada, “Third Annual Report on Medical Assistance in Dying in Canada 2021,” report on plans and priorities;transparency - other, July 26, 2022, https://www.canada.ca/en/health-canada/services/publications/health-system-services/annual-report-medical-assistance-dying-2021.html; Lemmens, “When Death Becomes Therapy.” [18] Coelho et al., “The Realities of Medical Assistance in Dying in Canada,” October 2023.; Bastidas-Bilbao et al., “Walking Alongside.” [19] Olivia Stefanovich, “Opposition Parties Call for Indefinite Pause to MAID Expansion for Mental Illness | CBC News,” Canadian Broadcasting Corporation, January 28, 2024, https://www.cbc.ca/news/politics/special-joint-committee-maid-mental-illness-report-1.7095679; Benjamin Lopez Steven, “Number of Assisted Deaths Jumped More than 30 per Cent in 2022, Report Says | CBC News,” Canadian Broadcasting Corporation, October 27, 2023, https://www.cbc.ca/news/politics/maid-canada-report-2022-1.7009704. [20] Hamer Bastidas-Bilbao et al., “Searching for Relief from Suffering: A Patient-Oriented Qualitative Study on Medical Assistance in Dying for Mental Illness as the Sole Underlying Medical Condition,” Social Science & Medicine 331 (August 1, 2023): 116075, https://doi.org/10.1016/j.socscimed.2023.116075. [21] Canadian Medical Association, “Canadian Medical Association Code of Ethics and Professionalism” (Canada: Canadian Medical Association, December 8, 2018), https://policybase.cma.ca/link/policy13937. [22] Canadian Medical Association. [23] Coelho et al., “The Realities of Medical Assistance in Dying in Canada,” October 2023; Stefanovich, “Opposition Parties Call for Indefinite Pause to MAID Expansion for Mental Illness | CBC News.” [24] John Paul Tasker, “Liberal Government Promoting a ‘culture of Death’ with Medical Assistance in Dying Law, Conservative MP Says | CBC News,” Canadian Broadcasting Corporation, March 6, 2023, https://www.cbc.ca/news/politics/culture-of-death-medical-assistance-in-dying-mental-illness-1.67695 04. [25] Coelho et al., “The Realities of Medical Assistance in Dying in Canada,” October 2023; Kayla Wiebe and Amy Mullin, “Choosing Death in Unjust Conditions: Hope, Autonomy and Harm Reduction,” Journal of Medical Ethics, April 26, 2023, https://doi.org/10.1136/jme-2022-108871. [26] Ramona Coelho et al., “The Realities of Medical Assistance in Dying in Canada,” Palliative & Supportive Care 21, no. 5 (October 2023): 871–78, https://doi.org/10.1017/S1478951523001025. [27] Konia Trouton et al., “Attitudes and Expectations Regarding Bereavement Support for Patients, Family Members, and Friends: Findings from a Survey of MAID Providers,” British Columbia Medical Journal 62, no. 1 (2020), https://bcmj.org/articles/attitudes-and-expectations-regarding-bereavement-support-patients-family-m embers-and.; William Robert Nielsen, “MAiD in Canada: Ethical Considerations in Medical Assistance in Dying,” Canadian Journal of Bioethics 4, no. 2 (December 9, 2021): 93–98, https://doi.org/10.7202/1084456ar. [28] Coelho et al., “The Realities of Medical Assistance in Dying in Canada,” October 2023. [29] Lemmens, “When Death Becomes Therapy.” [30] William Robert Nielsen, “MAiD in Canada: Ethical Considerations in Medical Assistance in Dying,” Canadian Journal of Bioethics 4, no. 2 (December 1, 2021): 93–98, https://doi.org/10.7202/1084456ar. [31] Steven, “Number of Assisted Deaths Jumped More than 30 per Cent in 2022, Report Says | CBC News.” [32] A. Plaisance et al., “Quebec Population Highly Supportive of Extending Medical Aid in Dying to Incapacitated Persons and People Suffering Only from a Mental Illness: Content Analysis of Attitudes and Representations,” Ethics, Medicine and Public Health 21 (April 1, 2022): 100759, https://doi.org/10.1016/j.jemep.2022.100759. (shrink)

Lack of supportive workplaces may be depriving babies and mothers of the health advantages of breastfeeding. This citizen science pilot project set out to engage women in photographing and sharing information on the available facilities for breastfeeding and expressing and storing breastmilk in Australian workplaces. While some useful insights were gained, the project failed in the sense that 234 people ‘liked’ the project Facebook page set up to recruit participants, but only nine photographs were submitted. The heaviest loss of (...) participation occurred after the ethics committee requirements were explained, in particular, the requirement for employer consent to take a photograph, or alternatively, for a participant to agree to bear the risk of taking a photo without permission. The ethics committee also made stipulations about the formality of language to be used. Thus, the project’s potential role as an enabler for health action was neutered. We argue that the ethics requirements worked contrary to our purpose and possibly acted to reinforce the powerlessness some women experience at work. (shrink)

In 2018 and 2019 Cancer Research UK (CRUK) launched a controversial advertising campaign to inform the British public of obesity being a preventable cause of cancer. On each occasion the advertisements used were emotive and provoked frustration among the British public which was widely vocalised on social media. As well serving to educate the public of this association, the advertisements also had the secondary effect of acting as health promotion through social marketing, a form of advertising designed to (...) influence behavioural changes. As CRUK delivered a public health message through its campaign, the advertisements should be held according to the ethical principles which underpin healthcare in the UK. This article evaluates whether the advertisements used by CRUK in 2018 and 2019 fulfilled the ethical principles of beneficence, autonomy, non-maleficence and justice. It is found that while providing an important message, the oversimplification of obesity as being the result of personal decisions ignored the complex aetiology and served to stigmatise the target demographic, potentially disengaging them from the message. Additionally, posting cancer as the consequence of obesity invokes feelings of fear due to its connotations of suffering and premature death. Based on available evidence, the use of fear in social marketing does not create sustained behavioural change. This essay recommends that CRUK discontinue its use of such strategies in its future social marketing endeavours. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:To Be or Not to Be:Waiving Informed Consent in Emergency ResearchCharles R. McCarthy (bio)The requirements for prior, legally authorized informed consent constitute a necessary condition for recruiting subjects into biomedical or behavioral research. However, informed consent requirements pose a serious problem for most research conducted in emergency care settings. For this reason, the Food and Drug Administration's (FDA) regulations governing investigational devices and the Department of (...) class='Hi'>Health and Human Services' (HHS) regulations for the protection of human subjects allow narrow exceptions to the general requirements of informed consent. In a joint effort to clarify the applicability of the current FDA regulations and to better understand the intent of the HHS regulations as they apply to emergency research, the FDA and the National Institutes of Health (NIH) cosponsored a public forum on the ethical conduct of emergency research in January 1995.Although the forum was not designed as a consensus conference and participants vigorously disagreed on some of the details, a broad consensus emerged on several major points: (1) both HHS and FDA regulations should, in the immediate future, be interpreted to allow for randomized clinical trials in emergency situations so long as the subjects are carefully protected; and (2) consideration should be given to producing new, closely harmonized regulations from both agencies that will provide greater clarity concerning what kinds of emergency research may be allowed without obtaining prior informed consent.The FDA-NIH forum in January was occasioned primarily by controversy about the hypothermia research protocol described below, but it is obvious that many other kinds of emergency research also await the outcome of deliberations concerning waiver of informed consent in emergency situations. These include research into the care and treatment of: occlusive stroke; subarachnoid hemorrhage due to intracranial aneurysm; metabolic coma; status epilepticus; cardiac arrest; myocardial infarction; cardiac arrhythmia; hemorrhagic shock; pulmonary embolism; acute asthmatic attack; and poisoning. All of these conditions [End Page 155] are encountered in emergency settings where obtaining informed consent from the patient-subjects to participate in research is seldom possible, and obtaining consent from legally authorized representatives of the subjects is either not feasible, or, if obtained, is of doubtful validity.The Hypothermia Research Case and HHS RegulationsA $7.2 million grant for research on the use of hypothermia in the treatment of severe head trauma, the largest award ever made to the University of Texas Health Sciences Center at Houston, is in danger of expiring before the study is completed. The protocol, which involves the use of cooling blankets to induce hypothermia in patients suffering from severe head injuries, is designed to test the hypothesis that: "Early lowering of the body temperature of patients suffering from severe head trauma to approximately 91 degrees Fahrenheit will slow patients' metabolism and will/will not, as a consequence, reduce the rates of both morbidity and mortality in these patients." The protocol was approved by seven Institutional Review Boards (IRBs), each of which waived the requirement to obtain informed consent from research subjects in accordance with Sec. 46. 116(d) of the HHS Regulations for the Protection of Human Subjects.1However, NIH's Office for Protection from Research Risks (OPRR), which is responsible for assuring compliance with the HHS regulations, has taken a controversial regulatory position by requiring informed consent from a legally authorized representative of each subject to be entered in the hypothermia trial. Because the obtaining of surrogate consent has proved to be very difficult, OPRR's position has slowed the research to a point where it may have to be terminated.At issue in the controversy is a fundamental question of ethics and public policy. Is it ever permissible to involve incompetent subjects in research without either their consent, or the consent of their legally authorized representatives? Pertinent HHS regulations for the protection of human subjects seem to answer the question affirmatively by allowing local IRBs to waive some or all of the elements of informed consent under carefully limited circumstances (45 CFR 46 116(d)). Nevertheless, OPRR has signalled the research community that use of the informed consent waiver provision for the Houston hypothermia study is not permitted under the regulations. OPRR judged that the risks... (shrink)

In 1997 President Clinton apologized to the survivors of the U.S. Public Health Service Syphilis Study. Since then, two of his recommendations have received little attention. First, he emphasized the need to remember the shameful past so we can build a better future for racial'ethnic minority populations. Second, he directed the creation in partnership with higher education to prepare training materials that would instruct biomedical researchers on the application of ethical principles to research with racial/ethnic minority populations. This (...) article proposes the inclusion of these issues in the implementation of the Affordable Care Act. It asks, What is the right or good thing to do? What are our obligations to one another? Two challenges are examined: (a) Conducting research with African Americans without knowledge of bioethics specific to this population, and (b) the ethical dilemma of conducting research that does not adequately take into account the diversity within the Black population that is a contributing factor in health disparities. Training and policy recommendations responsive to President Clinton's Apology are presented. (shrink)

This paper considers concerns that social care research may be stifled by health-focused ethical scrutiny under the Mental Capacity Act 2005 and the requirement for an ?appropriate body? to determine ethical approval for research involving people who are deemed to lack capacity under the Act to make decisions concerning their participation and consent in research. The current study comprised an online survey of current practice in university research ethics committees (URECs), and explored through semi-structured interviews (...) the views of social researchers engaged in or exploring work concerning people who may, under the Act, lack the capacity to make decisions to consent to participate in a research programme. The paper concludes that there was a lack of overt knowledge of and reference to the implications of the Act for research and some concerns that a restrictive focus on health-related scrutiny might prevent social care research from taking place. There was also a degree of creativity shown by social care researchers in responding to changing demands and a wish to assist people in making decisions to participate where possible. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:The Blossoming of Bioethics at NIHEzekiel J. Emanuel (bio)The establishment of the Department of Clinical Bioethics at the Warren G. Magnuson Clinical Center of the National Institutes of Health (NIH) has coincided with a burgeoning of interest and activity related to bioethical issues at NIH. The department has precipitated a reexamination and revitalization of existing bioethics activities in the Clinical Center and has launched new programs especially in (...) the areas of education and research. In addition, the department contributes to the work of others throughout NIH who address bioethical issues.The Organizational Location of the Department of Clinical BioethicsBefore describing the history and current activities of the Department of Clinical Bioethics, I will say something about it administrative location. Comprehension of the department’s organizational location is essential to understanding its history, role, and function. Prior to interviewing for the position of chair of the department, I did not—and, if truth be told, still do not fully—understand the details of the organizational structure of NIH. I therefore assume that many other bioethicists outside of the Institutes, especially those who do not regularly receive NIH funding, may not fully grasp its organizational intricacies.The Department of Clinical Bioethics is a department within the Warren G. Magnuson Clinical Center, which is NIH’s “hospital.” Hospital is in quotes because all of the patients at the Clinical Center must be enrolled in a research protocol and, therefore, are research subjects. The Clinical Center is where NIH’s clinical researchers admit their research subjects or see them in the out-patient setting. The Department of Clinical Bioethics reports directly to the Director of the Clinical Center, John I. Gallin, M.D., and receives its finances, space, and other resources from the Clinical Center.In this way, the department is part of NIH’s intramural (“inside”) program. People employed by NIH conduct intramural research, training, and other initiatives. The extramural program, which receives approximately 87 percent of NIH’s budget, funds research at institutions outside NIH. The extramural program awards grants and contracts for research, training, and conferences conducted [End Page 455] by investigators who are not affiliated with NIH. The National Human Genome Research Institute’s ELSI (Ethical, Legal, and Social Implications) program, for example, is part of NIH’s extramural program. As part of the NIH intramural program, the Department of Clinical Bioethics is not empowered to fund independent initiatives of people outside of NIH through grants and contracts. However, the department can collaborate with bioethicists and others on research, educational, and other programs outside of NIH and has some funds to support these collaborations.In addition, it is important for bioethicists to understand that NIH is a collection of 24 institutes and centers. Although there is coordination and collaboration between the institutes and centers, each is funded separately, and each has its own scope, programs, administrative structures, research agendas, training priorities, boards of advisors, and so forth. In this sense, NIH is more like a university that has many distinct schools, each with its own dean, faculty, budget, and fund raising office, than one that is tightly integrated and centrally-administered. Within NIH’s diffuse administrative structure, the Department of Clinical Bioethics is located within one of the centers (the Clinical Center) and has defined authority and responsibility only for bioethics within that center; in addition, because the Clinical Center’s mission is to support clinical research at other institutes, the department’ mission includes supporting the work of those institutes as well. Intellectual exchanges and relationships with other institutes and centers are neither pre-ordained nor administratively established; such relationships must be developed case-by-case, topic-by-topic, and initiative-by-initiative.The History and the Development of the Department of Clinical BioethicsThe Department of Clinical Bioethics was launched in late 1996. Although the department’s creation marked a major commitment to bioethics by the Clinical Center, and especially by its director, Dr. Gallin, it was formed on a pre-existing foundation of bioethics activities at NIH. 1In 1977, John Fletcher, Ph.D., was appointed by then Director Mortimer Lipsett as the bioethicist at the Clinical Center; his official title was Assistant for Bioethics... (shrink)

: Catholic teaching has no moral difficulties with research on stem cells derived from adult stem cells or fetal cord blood. The ethical problem comes with embryonic stem cells since their genesis involves the destruction of a human embryo. However, there seems to be significant promise of health benefits from such research. Although Catholic teaching does not permit any destruction of human embryos, the question remains whether researchers in a Catholic institution, or any researchers opposed to destruction (...) of human embryos, could participate in research on cultured embryonic stem cells, or whether a Catholic institution could use any therapy that ultimately results from such research. This position paper examines how such research could be conducted legitimately in a Catholic institution by using an ethical analysis involving a narrative context, the nature of the moral act, and the principle of material cooperation, along with references to significant ethical assessments. It also offers tentative guidelines that could be used by a Catholic institution in implementing such research. (shrink)

There is significant research value in the secondary use of surplus human tissue which has been removed during clinical care and is stored in diagnostic archives. However, this value is limited without access to information about the person from whom the tissue was removed. As the research value of surplus tissue is often not realised until after the patient’s episode of care, it is often the case that no consent has been given for any surplus tissue to be (...) used for research purposes. The Human Tissue Act 2004 does permit research use of surplus tissue without consent, but the researcher must not be in possession of information which could identify the person from whom the tissue was removed. Due to the commonly applied ‘consent or anonymise’ approach, linking tissue and data is challenging and full anonymisation would likely render much research on surplus tissue ineffectual. This article suggests that in recognising the value in surplus tissue linked with information about the person, a ‘share and protect’ approach which considers safeguards other than anonymisation, where obtaining consent for research use would not be feasible, would better balance the public benefit of health research with the protection of individual rights and interests than a requirement for either consent or anonymisation. (shrink)

Many opinions and ideas about aging exist. Biological theories have taken hold of the popular and scientific imagination as potential answers to a “cure” for aging. However, it is not clear what exactly is being cured or whether aging could be classified as a disease. Some scientists are convinced that aging will be biologically alterable and that the human lifespan will be vastly extendable. Other investigators believe that aging is an elusive target that may only be “statistically” manipulatable through a (...) better understanding of the operational principles of systems situated within complex environments. Not only is there confusion over definitions but also as to the safety of any potential intervention. Curing cell death, for example, may lead to cell cancer. The search for a cure for aging is not a clearly beneficial endeavour. This paper will first, describe contemporary ideas about aging processes and second, describe several current life extension technologies. Third, it analyses these theories and technologies, focusing on two representative and differing scientific points of view. The paper also considers the public health dilemma that arises from life extension research and examines two issues, risk/benefit ratio and informed consent, that are key to developing ethical guidelines for life extension technologies. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 15.2 (2005) 199-210 [Access article in PDF] Conflict-of-Interest Policy at the National Institutes of Health: The Pendulum Swings Wildly* Evan G. DeRenzo **This article addresses the National Institutes of Health (NIH) employee conflict-of-interest (COI) policy that went into effect February 2005. It is not, however, merely an account of another poorly crafted government policy that cries out for revision. Instead, it is (...) also a story about one of our nation's most important and prestigious institutions and its struggles to navigate the crosscurrents of scientific aspirations, power politics, public ambivalence toward capitalist economics in the biosciences, and the media's inclination to exaggerate problems and under report complicated facts. It is also a tale of greed, politics, purgatory, and redemption. The dramatic and abrupt change in the NIH COI policy demonstrates the difficulty of balancing the production of cutting-edge science with the demands for transparency resulting from work performed in the public interest on the public tab. It is an unhappy chapter in the life of a government agency that is also a national treasure. And, one hopes, it will be an example of how harmful and ill-conceived law can be revised and amended to advance national health and well-being. What is the New NIH COI Policy? The new NIH COI employee policy, more accurately referred to as the Interim Final Rule (Federal Register 2005), is a sweeping set of prohibitions on activities and holdings to reduce the possibility that NIH employees will have any actual [End Page 199] or apparent conflicts of interest. For the most part, the prohibitions are applied across-the-board—i.e., without distinction to employee category or function. The new policy includes prohibitions on outside activities, stock holdings, and awards. It prohibits all NIH employees from engaging in any compensated or uncompensated employment, including consulting, serving on advisory or other such boards, and compensated teaching, speaking, writing, or editing with certain kinds of entities. The first class of such entities is referred to as substantially affected organizations, defined as biotechnology, pharmaceutical, medical device companies, and others with similar interests. But these are not the only entities included in the prohibitions. Other organizations from which NIH employees now are cut off are hospitals, clinics, and other health care institutions; health, science, or health research-related professional associations and consumer and advocacy groups. Included also are educational institutions and not-for-profit independent research institutes that are, or were, recent NIH funding applicants, grantees, contractors, or cooperative research and development agreement (CRADA) partners. The only exemptions appear to be for health care institutions at which NIH employees provide clinical care and some forms of writing—e.g., an NIH physician who moonlights at her/his local hospital's emergency room or submits a manuscript to a peer-reviewed journal that receives only unrestricted funding from a prohibited entity. Prohibited and/or restricted holdings include stock in biotechnology, pharmaceutical, and medical device companies and others in research, development, or manufacture of medical devices, equipment, preparations, treatments, or products. The prohibitions apply to senior NIH employees; restrictions in the amount of such holdings apply to all remaining employees. Both apply to the spouses and minor children of NIH employees. If an NIH employee wins an award, the monetary allowance in most cases is limited to $200. In sum, the scope of this policy is vast, too vast to be reasonable. Too many employees are restricted in too many ways. Where appropriate restrictions have been placed on senior NIH employees, even these constructive aspects of the policy are overshadowed by the unfairness and destructiveness of other aspects. This policy far exceeds anything that could be considered sound. Fortunately, the policy has a built-in assessment process to begin at the end of the policy's first year of implementation. One can only hope that a fair and open evaluation will be conducted, the results of which surely must result in major revisions to what is now bad regulation. Why the Policy... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:PHARAOH'S.MAGICIANS: THE ETHICS AND EFFICA:CY OF HUMAN FETAiL TISSUE TRANSPLANTS ROBERT BARRY, O.P. Program for the Study of Religion University of Illinois, Champaign-Urbana DARREL KESLER Department of Animal Sciences University of Illinois, Champaign-Urbana. IN RECENT YEARS increasing attention ha;s been given to v:rurious types of scientific riese,arch involving the human fetus. In the 1970s, :a tremendous amount of concern was expres1 sed IJ.'egiaroing the fetus,a;.s a rSU!bject of e~erimenrtation. (...) In this debate, the announced " research impeiiat:i:ve " was pos,ed against other moral imperativ;es.1 Following much soctiet :JaJl drebarte, protootlive meiaisumeis 1 WeIDe il!dopited 1by oompireihensive regiutatiions in 1975 estaiblishiing protections foT a number of research sUibjects. These regulrutions protect the fetus from non-beneficiail experimentation. that iworuild pose more than minima;l risk rto the fetus. Current debates in science and ethics now swirl arlOiund a new topic regarding human '.fetal life: the fetus as a sourrce of tissue for triansplaintation into other persons ais run e~erimental thempy. It is an issue that is rapidly moving torward the same Jevel of" research imperative" as did the earlier debate on the 1 See Paul Ramsey, The Ethics of Fetal Research (New Haven: Yale University Press, 1975): "Today one often hears statements like' Fetal Research must be done,' or 'It would be immoral not to do this research'" (P. xv). The validity of such opinions and utterances entirely depends on a netbenefits ethics, and the validity of that moral universe has been called increasingly into question in recent years. 575 576 ROBERT BARRY, O.P. AND DARREL KESLER ~etus as subject. Recently,,a new level of intensity was added to this deharte rby the imposition of an indefinite moratorium on federal support for research on transplantrution experiments inv;olving human.fetirul tissue and other!humans. 1Thls " :indefinite moratorium " w1as a result of a process that 1 began with research p110posaJs considered rby the National In- 'stituites of Health (NIH) in October 1987. In Marich 1988 a momtorium wa;g plaioed on the r:eseareh, and an 1advisory panel was summoned to consider the ethical issues involved. This panel presented 1a cveoommendation for the procedures. However, the Secretary of the Department of Health and Ruman Se1wfoes (HHS), Dr. Louis Sullivan, decided against the research proposal on etmcal grounds. His decision w:as with the 'concU'l'Tenoe of the Assistant Secretary :£m.· Health of HHS, Dr. James Mason, who has Tespons~bility for the NIH. Secretary SulliV1an's decision was oommumcarted to the Acting Director of the NIH, Dr. William Raub, in Nov,ember 1989. A :firestorm of criticism erupted from,rudv;ocates of this research, including the Council of Judicial and Ethical Affairs of tihe American Medical Association, which 5.n June 1989 called for an end to the:ban.2 In this article, we wish to question both the science and the ethics of the rproposed fotal tissue transplantation therapy. We!Will 1support the £edeml funding moratorium and surggest new pmtections for the fetuses (whether po,ssibly living or de2 " Medical Applications of Fetal Tissue Transplantation", JAMA, Vol. 263, No. 4, January 26, 1990, 'PP· 565-570. There has been a.great deal of public debate, not only in the U.S. but also in Europe over whether human embryo research should be supported with public funds. Many Catholic countries in Europe have prohibited such research, while a number of other nations have allowed it. Dickson, D., "Europe Split on Embyro Research", Science, Vol. 242, November 21, 1988, pp. 1117-1118. The most interesting controversy is in West Germany where there is a strong movement to prohibit it because many there believe such an experimentation requires judgments that there are certain forms of human life that do not deserve to survive. Ibid., p. 1117. Many Germans regard these sorts of judgments as too close to those made by Nazis, and there is strong sentiment to prohibit such research altogether. Ibid. HUMAN FETAL TISSUE TRANSPLANTS 577 oea:sed) of elective a.bortfons. We will also describe new reseaooh directions in t~apy.for the diseases in which it is claimed that fetal... (shrink)

Very few data exist in France on: (1) nurses’ knowledge and behaviour concerning ethical decisions in clinical practice; and (2) their knowledge of ethical rules in clinical research. This questionnaire-based audit tried mainly to assess these questions in a large French university teaching hospital. Of the 257 questionnaires distributed to nurses in 23 clinical units of the hospital, 206 were returned (80% response rate). When responding to the vignette describing a clinical situation requiring an ethical decision to be made, (...) most nurses acted as the patient’s advocate although they have had no formal training in ethics. Indeed, 66% of nurses responding considered that the patients themselves should be the primary decision makers in situations that relate to their health and medical care. For children or comatose patients, the decision should be left to the relatives according to 72% of the responses. The results indicated that the role of health care professionals in ethical decisions made for a given patient should be marginal. Nurses’ knowledge concerning research protocols, particularly their ethical requirements and consequences, is poor at present and information from and communication with doctors should be improved. (shrink)

Since their revelation to the public, the sexually transmitted disease experiments in Guatemala from 1946 to 1948 have earned a place of infamy in the history of medical ethics. During these experiments, Public Health Service researchers intentionally exposed over 1,300 non-consenting Guatemalan soldiers, prisoners, psychiatric patients, and commercial sex workers to gonorrhea, syphilis, and/or chancroid under conditions that have shocked the medical community and public alike. Expert analysis has found little scientific value to the experiments as measured by current (...) or contemporaneous research standards.Such an obvious case of research malfeasance, which violated research norms in place both in the past and now, has been uniformly repudiated. The Guatemala STD experiments were labeled “clearly unethical” by President Barack Obama and “reprehensible” by the Secretaries of State and Health and Human Services. (shrink)

The paper problematises the reliability and ethics of using social media data, such as sourced from Twitter or Instagram, to carry out health-related research. As in many other domains, the opportunity to mine social media for information has been hailed as transformative for research on well-being and disease. Considerations around the fairness, responsibilities and accountabilities relating to using such data have often been set aside, on the understanding that as long as data were anonymised, no real ethical (...) or scientific issue would arise. We first counter this perception by emphasising that the use of social media data in health research can yield problematic and unethical results. We then provide a conceptualisation of methodological data fairness that can complement data management principles such as FAIR by enhancing the actionability of social media data for future research. We highlight the forms that methodological data fairness can take at different stages of the research process and identify practical steps through which researchers can ensure that their practices and outcomes are scientifically sound as well as fair to society at large. We conclude that making research data fair as well as FAIR is inextricably linked to concerns around the adequacy of data practices. The failure to act on those concerns raises serious ethical, methodological and epistemic issues with the knowledge and evidence that are being produced. (shrink)

Boundaries between research and clinical practice blur in health research conducted by clinician-researchers. We describe a typology, of clinician-researcher dual-role tensions, with two overarching catalysts: acting as a clinical resource for patient-participants and forming researcher–participant relationships mirroring clinician–patient relationships. Using the typology as an analytic template we explored blurred boundaries in five illustrative, non-clinician, critical studies. Like clinician-researchers, critical researchers act in ways that promote rapport and relationships with their participants, which can blur boundaries. While clinician-researchers see (...) tension between clinician and researcher roles, we ask what roles critical researchers attempt to distinguish: ethically minded citizen and researcher, socially conscious community member and researcher, or friend and researcher? Anticipating catalysts of dual-role tension may assist critical researchers in planning and conducting robust research. (shrink)

Intensified and extensive data production and data storage are characteristics of contemporary western societies. Health data sharing is increasing with the growth of Information and Communication Technology platforms devoted to the collection of personal health and genomic data. However, the sensitive and personal nature of health data poses ethical challenges when data is disclosed and shared even if for scientific research purposes. With this in mind, the Science and Values Working Group of the COST Action CHIP (...) ME ‘Citizen's Health through public-private Initiatives: Public health, Market and Ethical perspectives’ identified six core values they considered to be essential for the ethical sharing of health data using ICT platforms. We believe that using this ethical framework will promote respectful scientific practices in order to maintain individuals’ trust in research. We use these values to analyse five ICT platforms and explore how emerging data sharing platforms are reconfiguring the data sharing experience from a range of perspectives. We discuss which types of values, rights and responsibilities they entail and enshrine within their philosophy or outlook on what it means to share personal health information. Through this discussion we address issues of the design and the development process of personal health data and patient-oriented infrastructures, as well as new forms of technologically-mediated empowerment. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Human Gene TherapyMary Carrington Coutts (bio)On September 14, 1990, researchers at the U.S. National Institutes of Health (NIH) performed the first approved gene therapy procedure on a four-year-old girl named Ashanti DeSilva. Born with a rare genetic disease, severe combined immune deficiency (SCID), Ashanti lacked a healthy immune system and was extremely vulnerable to infection. Children with SCID usually develop overwhelming infections and rarely survive to adulthood; even (...) a common childhood illness like chicken pox is life-threatening. Ashanti led a cloistered existence, avoiding contact with people outside her family, remaining in the sterile environment of her home, and battling frequent illnesses with massive amounts of antibiotics.In Ashanti's gene therapy procedure, her own white blood cells were genetically modified and then infused back into her bloodstream. Laboratory tests show that the therapy has strengthened Ashanti's immune system. She no longer has recurrent colds, has been allowed to attend school, and has been immunized against whooping cough. This gene therapy procedure is not a cure, however. The genetically-treated white blood cells only survive for a few months and must then be replaced, but Ashanti's future is much brighter because of the new therapy (VI, Thompson [The First] 1993).Although this simplified description of Ashanti's gene therapy procedure sounds like a happy ending, it is little more than an optimistic chapter in a long story. The road to the first approved gene therapy procedure was rocky and fraught with controversy. The biology of human gene therapy is very complex, and there are still many techniques that need to be developed and diseases that need to be understood more fully before gene therapy is well established. The public policy debate surrounding the possible use of genetically engineered material in human subjects is equally complex. Major participants in the debate come from the fields of biology, government, law, medicine, philosophy, politics, and religion, each bringing different views to the discussion.In studying the ethics of gene therapy, one should draw a distinction between [End Page 63] therapy on somatic (non-reproductive) cells and germ (reproductive) cells. Only the germ cells carry the genes that will be passed on to the next generation. Reactions to gene therapy have varied widely. Some commentators on gene therapy object to any form of genetic manipulation, no matter how well-intentioned (VI, Rifkin 1983). Another reaction is to allow the use of somatic-cell therapy, but not to approve the use of germ-line therapy, which could have unforeseeable effects on future generations. A different stance is that, with proper regulation and safeguards, germ-line gene therapy is a logical extension of the progress made to date and that it is an ethically acceptable procedure.TechniquesTo date, 43 research protocols have been approved for somatic-cell gene therapy in the United States. The techniques employed in each protocol vary, but in general a virus is used as a "vector" to insert the desired gene into the DNA of the patient's cells, in order to compensate for a defective gene. For Ashanti's gene therapy, this technique involved obtaining white blood cells and introducing properly functioning genes into as many of the cells as possible. The normal genes were delivered through the use of a specially-engineered virus.Although similar techniques are used in germ-line gene therapy, the procedure is more difficult. There are two basic ways to perform germ-line gene therapy: (1) to treat a preimplantation embryo that carries a serious genetic defect before its implantation in the mother, which necessitates the use of in vitro fertilization techniques; or (2) to treat the germ cells (sperm or egg cells) of afflicted adults so that the genetic defects would not be passed on to their offspring, which requires the technical expertise to delete the defective gene and insert a properly functioning replacement. Because of the complexity of the procedures involved and the attendant ethical controversy, germ-line therapy is not currently performed.Candidate Diseases for Gene TherapyAt present, gene therapy is likely to be most successful in treating diseases that are caused by single-gene defects and has been approved for treating diseases such... (shrink)

Background: Family members are often required to act as substitute decision-makers when health care or research participation decisions must be made for an incapacitated relative. Yet most families are unable to accurately predict older adult preferences regarding future health care and willingness to engage in research studies. Discussion and documentation of preferences could improve proxies' abilities to decide for their loved ones. This trial assesses the efficacy of an advance planning intervention in improving the accuracy of (...) substitute decision-making and increasing the frequency of documented preferences for health care and research. It also investigates the financial impact on the healthcare system of improving substitute decision-making. Methods/DesignDyads (n = 240) comprising an older adult and his/her self-selected proxy are randomly allocated to the experimental or control group, after stratification for type of designated proxy and self-report of prior documentation of healthcare preferences. At baseline, clinical and research vignettes are used to elicit older adult preferences and assess the ability of their proxy to predict those preferences. Responses are elicited under four health states, ranging from the subject's current health state to severe dementia. For each state, we estimated the public costs of the healthcare services that would typically be provided to a patient under these scenarios. Experimental dyads are visited at home, twice, by a specially trained facilitator who communicates the dyad-specific results of the concordance assessment, helps older adults convey their wishes to their proxies, and offers assistance in completing a guide entitled My Preferences that we designed specifically for that purpose. In between these meetings, experimental dyads attend a group information session about My Preferences. Control dyads attend three monthly workshops aimed at promoting healthy behaviors. Concordance assessments are repeated at the end of the intervention and 6 months later to assess improvement in predictive accuracy and cost savings, if any. Copies of completed guides are made at the time of these assessments. DiscussionThis study will determine whether the tested intervention guides proxies in making decisions that concur with those of older adults, motivates the latter to record their wishes in writing, and yields savings for the healthcare system. Trial RegistrationISRCTN89993391. (shrink)

BackgroundThe Freedom of Information Act (FOIA) provides access to unreleased government records that can be used to enhance the transparency and integrity of biomedical research. We characterized FOIA requests to Department of Health and Human Services (HHS) agencies, including request outcomes, processing times, backlogs, and costs.MethodsUsing HHS FOIA annual reports, we extracted data on the number of FOIA requests received and processed by HHS agencies between 2008 and 2017, as well as request outcomes. Processing times were reported in (...) three time increments, < 1–20, 21–60, or 61+ days, and trends in backlog status were also described. Information about costs and fees collected were aggregated.ResultsBetween 2008 and 2017, 69.6% of 530,094 HHS FOIA requests were received by the Centers for Medicare and Medicaid Services (CMS), 18.9% by the Food and Drug Administration (FDA), and 11.6% by all other HHS agencies. During this period, CMS processed 374,728 requests, FDA 114,938, and other HHS agencies 61,890. CMS and FDA reduced backlogged requests by 9396 (89.7%) and 4289 (65.3%), respectively, leaving backlogs of 1081 and 2279 requests at the end of 2017. CMS fully or partially granted 60.3% of requests whereas FDA fully or partially granted 72.4%. Of all requests to CMS, 82.0% were considered simple and 18.0% complex; 82.2% of simple requests and 54.9% of complex requests were processed in 20 days, and 5.6% and 29.9% were processed in 61+ days. In contrast, 60.2% of requests to FDA were considered simple and 39.8% complex; 28.8% of simple requests and 9.0% of complex requests were processed in 20 days, and 58.3% and 81.5% were processed in 61+ days. The costs to HHS associated with FOIA requests totaled $446.4 million ($809 per processed request), increasing from $28.1 million ($423 per request) in 2008 to $53.3 million ($1544 per request) in 2017. In total, HHS collected $8.5 million in fees (1.9% of total costs).ConclusionsFOIA is frequently used to obtain information about HHS and its agencies. With growing costs, minimal fees collected, and lengthy processing times, HHS agencies’ FOIA programs might be made more efficient through greater proactive record disclosure. (shrink)

The field of bioethics has evolved over the past half-century, incorporating new domains of inquiry that signal developments in health research, clinical practice, public health in its broadest sense and more recently sensitivity to the interdependence of global health and the environment. These extensions of the reach of bioethics are a welcome response to the growth of global health as a field of vital interest and activity. This paper provides a critical interpretive review of how (...) the term “global health ethics” has been used and defined in the literature to date to identify ethical issues that arise and need to be addressed when deliberating on and working to improve the discourse on ethical issues in health globally. Selected publications were analyzed by year of publication and geographical distribution, journal and field, level of engagement, and ethical framework. Of the literature selected, 151 articles were written by authors in high-income countries, as defined by the World Bank country classifications, 8 articles were written by authors in low- or middle-income countries, and 13 articles were collaborations between authors in HIC and LMIC. All of the articles selected except one from 1977 were published after 1998. Literature on global health ethics spiked considerably from the early 2000s, with the highest number in 2011. One hundred twenty-seven articles identified were published in academic journals, 1 document was an official training document, and 44 were chapters in published books. The dominant journals were the American Journal of Bioethics, Developing World Bioethics, and Bioethics. We coded the articles by level of engagement within the ethical domain at different levels: interpersonal, institutional, international, and structural. The ethical frameworks at use corresponded to four functional categories: those examining practical or narrowly applied ethical questions; those concerned with normative ethics; those examining an issue through a single philosophical tradition; and those comparing and contrasting insights from multiple ethical frameworks. This critical interpretive review is intended to delineate the current contours and revitalize the conversation around the future charge of global health ethics scholarship. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Ethics CommentaryMichael Robertson, Senior Research FellowThe French philosopher Michel Foucault once recounted the story of the English King, George III, being restrained by his guards at the direction of his physician Dr. Willis. King George, presumably deranged by a psychotic mania consequent upon porphyria, was incapable of self-rule and his power was usurped by the medical profession in an act of coercion tantamount to treason. This for Foucault (...) was a profound metaphor of psychiatric power.1The plight of Mdm. W yokes the two most emotive issues in psychiatry — involuntary treatment and the administration of ECT. Whilst only utilised at an extremity of clinical practice, both of these are the most misunderstood of actions performed by the psychiatric profession. Yet, in many circumstances, they are life-saving.In essence, we are confronted with a profoundly depressed woman, whose illness is seemingly resistant to first line treatment and poses a serious, credible risk of harm. Most psychiatrists would regard this as somewhat of a psychiatric emergency. We are informed that Mdm. W’s family has transcended any cultural taboos about mental illness and is engaged in her care, has an extensive lived experience of her severe mood disorder and accepts, indeed welcomes, the use of ECT to terminate a severe episode of depression. In the course of a psychotic depression, Mdm. W is suffering profound distress and presents a risk of either suicide or serious medical complications if the episode persists. Despite the minimal discomfort during the actual administration of ECT, Mdm. W’s distress will be compounded by the further restraint needed to prevent from her eating and drinking prior to anaesthesia.It is difficult to know what Mdm. W’s experience of this situation would [End Page 230] be. Through the prism of her disturbed mental state, with its derangements in thinking, cognitive functioning and apprehension of reality, she would likely experience the situation as one of fear or terror; she would likely interpret ECT and the enforced restriction of oral intake prior to the procedure as punitive — further evidence of her “sins”, reinforcing her delusional guilt and nihilism. Yet to speak to Mdm. W in circumstances of euthymia or normal mood, where such derangements no longer occur, might reveal an utterly different perspective on the situation. Like many people with episodic mental illnesses, Mdm. W might, when such a scenario was put to her, consent to future treatment with ECT without equivocation. Indeed, many patients with bipolar disorder formulate advance directives in regard to the specific management of their possible future episodes of illness.If the clinical and legal aspects of this situation are so clear, why is there a sense of a dilemma in the realm of clinical ethics? Beyond the emotive nature of the situation, we see a deeply distressed woman being provided potentially life-saving treatment, which is being denied to her by the profound impairments of insight and judgement consequent upon her illness.In Singapore, such detention and enforced treatment under the Mental Capacity Act (2010) applies to a person with a mental illness or disorder who lacks capacity to make decisions in their own best interests based upon impairment of mind or brain. This would be considered a “capacity” based mental health law. In other jurisdictions, the legal test and evidentiary justification for such care may be predicated upon risk of harm to self or others. In either setting, Mdm. W’s clinical situation provides adequate legal justification for such enforced care.The moral justification of such laws falls into two general categories — the “risk” argument and the “capacity” argument. In mental health legislation, the “harm principle”, as first elaborated in John Stuart Mill’s On Liberty,2 is usually defined in terms of the construct of “risk”. Risk is a term that has multiple meanings in different disciplinary contexts, although all approaches to “risk” attempt to apply knowledge to an area of uncertainty.3 The notion of “risk assessment” is usually considered as the process of categorising individuals by their perceived likelihood of causing serious harm to themselves or harm to others. In the insurance industry, actuarial assessment is a mathematical discipline aimed at computing a probability of adversity... (shrink)

The Covid‐19 pandemic has revealed myriad social, economic, and health inequities that disproportionately burden populations that have been made medically or socially vulnerable. Inspired by state and local governments that declared racism a public health crisis or emergency, the Anti‐Racism in Public Health Act of 2020 reflects a shifting paradigm in which racism is considered a social determinant of health. Indeed, health inequities fundamentally rooted in structural racism have been exacerbated by the Covid‐19 pandemic, which (...) calls for the integration of antiracist praxis to promote ethical public health research processes. This commentary describes ways in which antiracist praxis—which emphasizes empowerment of traditionally marginalized populations—offers strategies to explicitly address power imbalance, stigmatization, and other consequences of structural racism in public health research. (shrink)

The draft Code of Conduct for Research is an important initiative towards assisting the scientific community in complying with the provisions of the Protection of Personal Information Act 4 of 2013 (POPIA). However, its approach towards cross-border data sharing should be reconsidered to clarify the ambiguities inherent in the legal requirements for the cross-border sharing of health data in the POPIA. These ambiguities include the concept of ‘transfer of information’, the application of adequacy as a legal mechanism for (...) transfer, the nature of consent for cross-border sharing and the scope of the recipient third party. We suggest that the draft Code of Conduct for Research can be improved by: Explaining or defining the concept of ‘transfer of information’ and when it applies to cross-border sharing in research Clarifying the application of adequacy as a legal mechanism for transfer vis-à-vis the other alternatives Expanding on the interpretation and application of consent as a legal mechanism for cross-border transfers Expanding the category of persons who may be recipients of personal information in a third country. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 12.1 (2002) 95-102 [Access article in PDF] Bioethics Inside the Beltway Some Initial Reflections on NBAC Eric M. Meslin and Harold T. Shapiro On 3 October 2001, Executive Order 12975 expired, and with it so too did the National Bioethics Advisory Commission (NBAC). Established by President Bill Clinton in 1995, NBAC was the fifth national committee since 1974 created to advise the U.S. government (...) on bioethics policy. In the long political tradition in this country that national bioethics policy advice should use temporary rather than permanent bodies, NBAC followed in the footsteps of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-78); the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (1980-83); the Ethics Advisory Board (1978-80); and the Biomedical Ethics Advisory Committee (1988-89). Arguably, other distinguished panels could lay claim to recognition as a "national bioethics committee" including the Advisory Committee on Human Radiation Experiments (ACHRE) (1994-95); the Fetal Tissue Transplantation Research Panel (1988); the Human Embryo Research Panel (1994); and the National Institutes of Health (NIH) Recombinant DNA Advisory Committee (RAC), which continues to function.These committees and commissions form a kind of a continuum, albeit occasionally interrupted by periods during which no such bodies existed. Each arose from a particular confluence of events and circumstances. NBAC was no different; its history can be traced both to a series of discussions within the White House Office of Science and Technology Policy beginning in 1993 (NBAC 1998a, p. 3), and to a specific recommendation from ACHRE that called for a national committee to address ethical issues in human subjects research (ACHRE 1995, p. 817). Nbac's Impact In his useful comparison of the accomplishments of the National Commission and the President's Commission, Brad Gray concluded that seven lessons were learned, the sixth of which was that "nothing substitutes for having a perceptible impact on either policy or practice" (Gray 1995, p. 304). Assessing NBAC's [End Page 95] impact on "policy or practice" is difficult, particularly given the fact that it so recently completed its work. More time may be needed before a full assessment can be undertaken of the impact of its six reports (and their total of 120 recommendations). Instead, in this essay we offer some reflections on NBAC's initial impact, using some specific examples of how bioethics gets done Inside the Beltway. Eliciting Reaction If immediate reaction by the White House is any measure of impact, then Cloning Human Beings (NBAC 1997) had a significant one. The day after he received this report in a Rose Garden ceremony, President Clinton submitted a bill to Congress that would have extended the moratorium on federal funding to create a child using somatic cell nuclear transfer. This bill never passed, nor has any other bill emerged that has enjoyed the support of the House and the Senate. Five states have enacted legislation to date, but these vary in their permissibility from bans on all forms of cloning to bans similar to the one proposed by NBAC, which recommended a time-limited prohibition only on somatic cell transfer to create a child (reproductive cloning).If the Cloning report elicited speedy action from the White House, this paled in comparison to the reaction that led to and, in turn, was created by Ethical Issues in Human Stem Cell Research (NBAC 1999a). Those who believe that government moves slowly need only be reminded of the events of 8-14 November 1998 (and, as we shall mention below, the further events of 14 July 1999). Some will recall that early in the second week of November 1998, James Thomson and his colleagues published in Nature and John Gearhart and his colleagues published in the Proceedings of the National Academy of Sciences that they had isolated and cultured human primordial stem cells and germ cells respectively. Within days of these remarkable reports, Advanced Cell Technology (ACT) announced via an article written by Nicholas Wade in the... (shrink)

BackgroundRandomized controlled trials (RCTs) are often complex and expensive to perform. Less than one third achieve planned recruitment targets, follow-up can be labor-intensive, and many have limited real-world generalizability. Designs for RCTs conducted using cohorts and routinely collected health data, including registries, electronic health records, and administrative databases, have been proposed to address these challenges and are being rapidly adopted. These designs, however, are relatively recent innovations, and published RCT reports often do not describe important aspects of their (...) methodology in a standardized way. Our objective is to extend the Consolidated Standards of Reporting Trials (CONSORT) statement with a consensus-driven reporting guideline for RCTs using cohorts and routinely collected health data.MethodsThe development of this CONSORT extension will consist of five phases. Phase 1 (completed) consisted of the project launch, including fundraising, the establishment of a research team, and development of a conceptual framework. In phase 2, a systematic review will be performed to identify publications (1) that describe methods or reporting considerations for RCTs conducted using cohorts and routinely collected health data or (2) that are protocols or report results from such RCTs. An initial “long list” of possible modifications to CONSORT checklist items and possible new items for the reporting guideline will be generated based on the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) and The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statements. Additional possible modifications and new items will be identified based on the results of the systematic review. Phase 3 will consist of a three-round Delphi exercise with methods and content experts to evaluate the “long list” and generate a “short list” of key items. In phase 4, these items will serve as the basis for an in-person consensus meeting to finalize a core set of items to be included in the reporting guideline and checklist. Phase 5 will involve drafting the checklist and elaboration-explanation documents, and dissemination and implementation of the guideline.DiscussionDevelopment of this CONSORT extension will contribute to more transparent reporting of RCTs conducted using cohorts and routinely collected health data. (shrink)

In a 2003 Science article, Eric Juengst and colleagues asserted, “NIH [National Institutes of Health] has a responsibility to help society respond to the implications of antiaging research for whic...

Despite changes to research and practice, that, to some degree, acknowledge that people are shaped by their contexts, the treatment of mental illness remains largely focused on interventions that take place at the level of the individual. Conceptualizing mental illness as something that resides in individuals can lead to reliance on neurobiological and psychotherapeutic solutions, and away from conversations about not only contextual causes of mental distress, but also sociopolitical solutions to mental distress. Further, it can lead to the (...) use of mental health interventions that focus on the biology of an individual without a consideration for how those interventions themselves may have psychological, social, or political consequences that act to shape an individual's identity, agency, and relationship to their community. This paper examines one medicolegal intervention, the community treatment order, using the philosophical work of Grosz and Foucault to consider how this intervention affects the experience and construction of identity, and the impact of this on an individual's sense of agential membership in a community. This discussion aims to increase understanding of the individual and social implications of interventions for mental illness, and provide a conceptualization of the relationship between identity, agency, and ethics which can inform critical research and nursing practice more broadly. (shrink)

Background Speaking up to safeguard patients is a crucial ethical and moral obligation for nurses, but it is also a difficult and potentially dangerous component of nursing work. Health advocacy is gaining impetus in the medical literature, despite being hampered by barriers resulting in many nurses in Ghana remaining mute when faced with advocacy-required situations. We explored situations that thwart nurses from performing their health advocacy role. Research question What would cause nurses to take no action when (...) they witness situations that require them to act as health advocates for their clients or communities? Research Design An inductive, descriptive qualitative design was used to collect and analyse data on barriers that prevent nurses from practising their health advocacy role in Ghana. Individual one-on-one in-depth interviews were conducted using a semi-structured interview guide. The data were analysed using qualitative content analysis. Participants and research context Twenty-four professional nurses and midwives registered with the Nursing and Midwifery Council were recruited from three regional hospitals in Ghana. These public hospitals were chosen from the upper, middle and coastal regions. Ethical considerations The UKZN Ethics Review Committee in South Africa and the GHS Ethics Review Committee in Ghana both gave their approval for this study. Findings Intrapersonal barriers, interpersonal barriers, and structural barriers emerged as major obstacles that nurses experience when performing their health advocacy role. Conclusions Barriers to health advocacy have undermined nurses' ability to function as health advocates and are preventing them from utilising their health advocacy position in nursing practise. Giving nursing students positive role models in the classroom and in the clinic can help them become more effective health advocates. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 12.3 (2002) 299-303 [Access article in PDF] Bioethics Inside the Beltway What Should IRBs Consider When Applying the Privacy Rule to Research? Julie Waltz Gerlach In 1996, Congress mandated the establishment of standards for the privacy of individually identifiable health information through the Health Insurance and Portability and Accountability Act of 1996 (HIPAA). Until the establishment of HIPAA, personal health (...) information could be distributed without notice or consent for reasons that had nothing to do with a patient's medical treatment or health care reimbursement. Patient information held by a health plan could be passed on to a lender who then might deny the patient's application for a home mortgage or a credit card or to an employer who might use it for personnel decisions. Congress failed to meet its 21 August 1996 deadline established by HIPAA to pass privacy legislation; the Act passed the responsibility to Department of Health and Human Services (DHHS). On 28 December 2000, the Secretary of Health and Human Services released final privacy regulations relating to the protection of patients' individually identifiable health information. The "Standards for Privacy of Individually Identifiable Health Information" (Privacy Rule/current) took effect 14 April 2001. As required by HIPAA, the Privacy Rule established conditions for the collection, use, and disclosure of protected health information by covered entities for research purposes. Covered entities, defined as health plans, health care clearinghouses, and health care providers that engage electronically in a wide range of financial and administrative transactions related to payment and reimbursement, must comply by 14 April 2003 (DHHS 2000, p. 82462). To ensure that the provisions of the final rule provide strong privacy protection without hindering access to health care, the Department of Health and Human Services (DHHS 2002, p. 14776) has proposed modifications to the Privacy Rule.The final Privacy Rule (DHHS 2001) grants substantial rights to individuals/research participants to be informed of how their protected health information is maintained and how that information may be used or disclosed. It also defines individual's/research participants' rights with regard to gaining access to information about themselves, when such information is held by covered entities. [End Page 299]The Privacy Rule requires researchers either to receive authorization from individuals/research participants to collect, use, and disclose protected health information, or to obtain a waiver of authorization that is approved by an institutional review board (IRB) or Privacy Board, or to use de-identified data. Section 164.508 of the Privacy Rule, entitled "Use and Disclosures for Which an Authorization Is Required," describes how IRBs will be directly affected. The rule focuses not just on research but on the overall privacy of all identifiable health information. Institutions have the option of adding these required duties to IRBs or establishing "privacy boards." Privacy boards, as defined by the Privacy Rule, are to be composed of members with varying backgrounds and professional competency to review the effect of the research protocol on the individual/research participant's privacy rights. The board must include at least one member who is not affiliated with the covered entity, or any entity conducting or sponsoring the research, and not related to any person who is affiliated with such entities. Board members cannot participate in the review of any research project in which the member has a conflict of interest.The basic concepts and tenets of privacy and confidentiality are well known to IRBs in the United States, which operate under the Common Rule (45 CFR 46) and/or the Food and Drug Administration's (FDA) human subject protection regulations. Both sets of regulations require IRBs to ensure that risks (including privacy risks) are minimized. Under these regulations, IRBs must consider the confidentiality of research data and whether researchers should have access to confidential medical information. IRBs also must review the consent form as a process of communication that will inform research subjects about the research study.One noteworthy aspect of the Privacy Rule is its application to all research regardless of funding source. Currently, research funded by... (shrink)

Mental health surveys are used extensively in epidemiological research worldwide. The ethical questions that arise regarding their risk of causing psychological distress or other potential harm have not been studied in the general population. We have investigated how study participants serving as controls in a population-based study perceived an anonymous postal questionnaire focusing on mental health and wellbeing. Parents were contacted from the Swedish Census Bureau as part of a larger follow-up study on palliative care conducted in (...) 2001. Eligible parents had a child of the same gender, year of birth and were from the same counties in Sweden as parents who had lost a child to cancer. Five percent reported being negatively affected. The principle negative effect on participants was that self-reflection reminded them of their difficulties. Of the 418 respondents, 52% reported that they were positively affected by study participation and 95% perceived the inquiry as valuable. These findings support the use of population-based controls in future research. (shrink)

Brazil has one of the highest levels of economic disparity in the world. The educational system plays a large role in this reality, acting as a mechanism of social exclusion. Neoliberalism has resulted in the commodification of education, empowering private schools while undermining the public system. This has created a vicious cycle, whereby educational inequality reflects and reinforces social inequality. Such a system violates the rights of children not lucky enough to be born into wealth – the right to equal (...) education; to equal opportunity; and equal treatment. From within this context, we propose a model, dubbed The Eagle’s Flight, for psychological intervention in public schools. This will form an extension of our research group’s Psychosocial Assessment and Intervention – Prevention, Community and Liberation, which has been an on-going project for the past fourteen years. The intervention model advocates monitoring child development from a critical, social and historical perspective, focusing on how school and community affect everyday life. The analysis will be carried out via the daily immersion of psychologists in the public school setting, who pay attention to key aspects which include various expressions of violence, financial difficulties related to unemployment, informal employment or drug dealing, poor access to health services, and the developmental impact of factors such as poverty. Based on Paulo Freire's Emancipatory Education Proposal and Ignacio Martín-Baró’s Liberation Psychology, intervention in school and community must be an interdisciplinary procedure, employing professionals from a range of disciplines involved in the study of child development. The various subjects’ perspectives seek to provide support for everyday problems and solutions, whilst breaking down the hegemonic model of psychological practice that considers the child and family as responsible for their problems. A concrete example of this critical psychosocial intervention model is presented. (shrink)

The Confidentiality Advisory Group (CAG) is a specialised body that advises the Health Research Authority (HRA) and the Secretary of State for Health on requests for access to confidential information, in the absence of informed consent from its owners. Its primary role is to oversee the safe use of such information and to counsel the governing bodies mentioned above as to whether such use is appropriate or inappropriate. Researchers who seek access to England or Wales-based confidential data, (...) for medical purposes that are in the interest of the public, are typically required to submit an application to this body. However, it is not always clear to researchers whether requests for access to patient data fit within the remit of the CAG or a Trust’s local information governance team. This commentary will, therefore, explore the role of the CAG and reflect on how best to support researchers with this question. (shrink)

The rapid expansion of research on Brain-Computer Interfaces is not only due to the promising solutions offered for persons with physical impairments. There is also a heightened need for understanding BCIs due to the challenges regarding ethics presented by new technology, especially in its impact on the relationship between man and machine. Here we endeavor to present a scoping review of current studies in the field to gain insight into the complexity of BCI use. By examining studies related to (...) BCIs that employ social research methods, we seek to demonstrate the multitude of approaches and concerns from various angles in considering the social and human impact of BCI technology. For this scoping review of research on BCIs’ social and ethical implications, we systematically analyzed six databases, encompassing the fields of medicine, psychology, and the social sciences, in order to identify empirical studies on BCIs. The search yielded 73 publications that employ quantitative, qualitative, or mixed methods. Of the 73 publications, 71 studies address the user perspective. Some studies extend to consideration of other BCI stakeholders such as medical technology experts, caregivers, or health care professionals. The majority of the studies employ quantitative methods. Recurring themes across the studies examined were general user opinion towards BCI, central technical or social issues reported, requests/demands made by users of the technology, the potential/future of BCIs, and ethical aspects of BCIs. Our findings indicate that while technical aspects of BCIs such as usability or feasibility are being studied extensively, comparatively little in-depth research has been done on the self-image and self-experience of the BCI user. In general there is also a lack of focus or examination of the caregiver’s perspective. (shrink)